2BATK603Altius Battery Charger

VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Altius ® High Frequency Nerve Block System Prescriber Instructions for Use Caution: Federal (US) law restricts this device to sale by or on the order of a physician. LB-0195 Rev X6 LB-0195 X6 Document Number Revision ALTIUS SYSTEM PRESCRIBER MANUAL DCO NUMBER: 23-0116 RELEASE DATE: June 23, 2023 Page 2 of 19 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Neuros Medical (USA), Inc 26800 Aliso Viejo Parkway, Suite 250 Aliso Viejo CA 92637, USA Support Phone Number: 883-240-4462 Altius® is a US registered trademark of Neuros Medical. The information provided in this document may change without prior notice. This document and its contents are proprietary to Neuros Medical. No part of this manual may be reproduced, distributed, or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Neuros Medical Please read the complete documentation provided before you use the device. Copyright © Neuros Medical Inc. 2023 ALL RIGHTS RESERVED. The Altius System® is protected by several U.S. Patents. For an up-to date list of relevant patents and patent applications, visit our patents page: https://www.neurosmedical.com/patents LB-0195 X6 Document Number Revision ALTIUS SYSTEM PRESCRIBER MANUAL DCO NUMBER: 23-0116 RELEASE DATE: June 23, 2023 Page 3 of 19 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Table of Contents 1. Indications for Use, Contraindications, Warnings and Precautions .................................. 5 1.1. Indications for Use ........................................................................................................ 5 1.2. Contraindications ......................................................................................................... 5 1.3. Operating Principle ....................................................................................................... 5 1.4. Warning ....................................................................................................................... 5 1.4.1. Use as indicated and instructed .............................................................................. 5 1.4.2. Diathermy ............................................................................................................. 6 1.4.3. Electromagnetic Interference (EMI) ........................................................................ 6 1.4.4. Case Damage ......................................................................................................... 8 1.4.5. Packaging, Sterilization and Single Use.................................................................... 8 1.4.6. Effects on other implanted devices ......................................................................... 8 1.4.7. Use in pediatric patients ......................................................................................... 9 1.4.8. Use in pregnant patients......................................................................................... 9 1.4.9. Use in diabetic patients .......................................................................................... 9 1.5. Magnetic resonance imaging (MRI) Safety Information ................................................... 9 1.6. Precautions .................................................................................................................10 1.6.1. Physician training .................................................................................................10 1.6.2. Storage and Operating Environments ....................................................................10 1.6.3. Component Handling ............................................................................................11 1.6.4. Patient Detoxification ............................................................................................11 1.6.5. Effect on electrocardiograms (ECGs) ......................................................................11 1.6.6. Charging system ...................................................................................................11 1.6.7. Information for the patient ....................................................................................11 1.7. Component disposal .....................................................................................................12 1.8. Patient selection ..........................................................................................................13 1.9. Long term effectiveness of Altius system .......................................................................13 2. Adverse events summary ..................................................................................................13 LB-0195 X6 Document Number Revision ALTIUS SYSTEM PRESCRIBER MANUAL DCO NUMBER: 23-0116 RELEASE DATE: June 23, 2023 Page 4 of 19 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document 3. Patient counseling information ..........................................................................................14 Appendix I: Electromagnetic interference ...............................................................................15 Information available for Neuros Altius system: The information for prescriber manual provides information about indications, contraindications, warnings, precautions, adverse events, sterilization, patient selection, individualization of treatment, and component disposal. Product manuals, such as programming guide, patient user guide, and implant manual provide device descriptions, package contents, device specifications, battery longevity and instructions for use. For information that supports the clinical use of the Altius system, refer to the clinical summaries manual. LB-0195 X6 D…

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Altius ® Direct Electrical Nerve Stimulation System Patient Manual Caution: Federal (US) law restricts this device to sale by or on the order of a physician LB-0196 Rev B ALTIUS SYSTEM PATIENT MANUAL LB-0196 Rev B/DCO 24-0096/Effective: TBD Page 2 of 27 Neuros Medical Inc. Confidential Document Neuros Medical (USA), Inc 26800 Aliso Viejo Parkway, Suite 250 Aliso Viejo CA 92656, USA Support Phone Number: 833-240-4462 Altius ® is a US registered trademark of Neuros Medical. The information provided in this document may change without prior notice. This document and its contents are proprietary to Neuros Medical. No part of this manual may be reproduced, distributed, or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Neuros Medical Please read the complete documentation provided before you use the device. Although FDA has determined that the probable benefits outweigh the probable risks, there remains some uncertainty regarding the manufacturer’s human factors engineering (HFE) and usability engineering (UE) analysis and validation testing. As a condition of approval, FDA is requiring the manufacturer to provide an HFE/UE analysis and validation testing and recommending that this analysis and testing is designed using the FDA’s 2016 guidance document “Applying Human Factors and Usability Engineering to Medical Devices” (https://www.fda.gov/media/80481/download). Copyright © Neuros Medical Inc. 2023 ALL RIGHTS RESERVED. The Altius ® System is protected by several U.S. Patents. For an up-to date list of relevant patents and patent applications, visit our patents page: http://www.neurosmedical.com/ patents ALTIUS SYSTEM PATIENT MANUAL LB-0196 Rev B/DCO 24-0096/Effective: TBD Page 3 of 27 Neuros Medical Inc. Confidential Document Table of Contents 1. Explanation of Symbols .................................................................................................................. 5 2. Introduction ..................................................................................................................................... 7 3. Indications for Use .......................................................................................................................... 7 4. Contraindications............................................................................................................................ 7 4.1. Altius System Contraindications ............................................................................................. 7 5. Warnings .......................................................................................................................................... 7 5.1. Warnings .................................................................................................................................. 7 5.2. Magnetic resonance imaging (MRI) Safety Information ........................................................ 9 5.3. Warnings about Other Medical Treatments ......................................................................... 10 6. Precautions .................................................................................................................................... 11 7. Adverse events .............................................................................................................................. 12 7.1. Surgical risks .......................................................................................................................... 12 8. Altius System Overview ............................................................................................................... 13 8.1. Altius System Altius System Implantable Pulse Generator & Cuff Electrode(s) ................ 13 8.2. Altius Patient Controller Overview ....................................................................................... 14 8.3. Altius Battery Charger Overview .......................................................................................... 15 8.4. Altius Programmer System Overview................................................................................... 15 9. Following Implantation Surgery ................................................................................................ 15 10. Living with the Altius System ...................................................................................................... 16 10.1. General Expectations ............................................................................................................. 16 10.2. Effect on Your Activities ........................................................................................................ 16 10.3. Medications ............................................................................................................................ 17 10.3.1. Pain Relief Medications ..................................................................................................... 17 10.3.2. General Medications .......................................................................................................... 17 10.4. The Importance of Your Patient ID Card .............................................................................. 17 11. Device Lifetime/Replacement .................................................................................................... 18 Appendix I: Additional Electromagnetic Precautions .................................................................... 19 Appendix II: Replaceable Parts & Cables .......................................................................................... 21 Appendix III: Wireless Specifications of the Altius System ........................................................... 22 Appendix V: Federal Communications Commission (FCC) ............................................................ 26 ALTIUS SYSTEM PATIENT MANUAL LB-0196 Rev B/DCO 24-0096/Effective: TBD Page 4 of 2…

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VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Altius ® Direct Electrical Nerve Stimulation System Implantable Pulse Generator Programmer Manual CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician LB-0197 Rev B LB-0197 B Document Number Revision ALTIUS SYSTEM IPG PROGRAMMER MANUAL DCO NUMBER: 24-0096 RELEASE DATE: TBD Page 2 of 40 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Neuros Medical (USA), Inc 26800 Aliso Viejo Parkway, Suite 250 Aliso Viejo CA 92656, USA Support Phone Number: 833-240-4462 Altius® is a US registered trademark of Neuros Medical. The information provided in this document may change without prior notice. This document and its contents are proprietary to Neuros Medical. No part of this manual may be reproduced, distributed, or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Neuros Medical Please read the complete documentation provided before you use the device. Although FDA has determined that the probable benefits outweigh the probable risks, there remains some uncertainty regarding the manufacturer’s human factors engineering (HFE) and usability engineering (UE) analysis and validation testing. As a condition of approval, FDA is requiring the manufacturer to provide an HFE/UE analysis and validation testing and recommending that this analysis and testing is designed using the FDA’s 2016 guidance document “Applying Human Factors and Usability Engineering to Medical Devices” Copyright © Neuros Medical Inc. 2023 ALL RIGHTS RESERVED. The Altius® System is protected by several U.S. Patents. For an up-to date list of relevant patents and patent applications, visit our patents page: http://www.neurosmedical .com/ patents LB-0197 B Document Number Revision ALTIUS SYSTEM IPG PROGRAMMER MANUAL DCO NUMBER: 24-0096 RELEASE DATE: TBD Page 3 of 40 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Table of Contents 1. Explanation of Symbols .......................................................................................................... 6 2. Altius Programmer System Overview ................................................................................... 7 2.1. Description of Altius Programmer System ....................................................................... 7 2.2. Programmer Functions .................................................................................................... 8 2.3. Programmer Components ................................................................................................ 8 2.4. Interconnecting the Programmer components for Operation ........................................... 8 2.5. Programmer Wand .......................................................................................................... 9 2.6. Charging the Battery of the Altius PAPC ......................................................................... 10 2.7. Operating the Altius Programmer System ...................................................................... 10 2.8. Using the Altius PAPC Touch Screen (If Available) ......................................................... 10 2.9. Buttons and Symbols on the Altius PAPC........................................................................ 11 2.10. Altius PAPC Battery Replacement .................................................................................. 11 2.11. Routine Cleaning ............................................................................................................ 11 2.12. Storage, Handling and Usage .......................................................................................... 11 2.13. Additional Notes ............................................................................................................ 12 2.14. Cautions and Warnings ............................................................................................... 13 2.14.1. Implanted components and MRI scans ............................................................... 13 2.14.2. Electromagnetic Interference ............................................................................. 13 2.14.3. Surgical Cautions and Warnings ......................................................................... 14 3. Altius Programmer Software Overview .............................................................................. 14 3.1. Altius Programmer Start-up ........................................................................................... 14 3.2. Basic Operation of the Altius Programmer Application .................................................. 15 3.2.1. Communicating with the Altius IPG ........................................................................ 15 3.2.2. Interrogation and Programming ............................................................................ 16 3.2.3. Monitoring Tools.................................................................................................... 16 3.2.4. Closing the Altius Programmer Application............................................................ 17 4. Altius Programmer Software Description .......................................................................... 17 4.1. Menu Bar ....................................................................................................................... 17 LB-0197 B Document Number Revision ALTIUS SYSTEM IPG PROGRAMMER MANUAL DCO NUMBER: 24-0096 RELEASE DATE: TBD Page 4 of 40 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document 4.1.1. File Menu ............................................................................................................... 18 4.1.2. Tools Menu ..........................................................................…

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VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Altius System ® Patient Controller and Battery Charger Manual Caution: Federal (US) law restricts this device to sale by or on the order of a physician LB-0199 Rev X7 LB-0199 X7 Document Number Revision ALTIUS PATIENT CONTROLLER AND BATTERY CHARGER MANUAL DCO NUMBER: 24-0010 RELEASE DATE: TBD Page 2 of 28 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Neuros Medical (USA), Inc 26800 Aliso Viejo Parkway, Suite 250 Aliso Viejo CA 92637, USA Support Phone Number: 883-240-4462 Altius ® is a US registered trademark of Neuros Medical. The information provided in this document may change without prior notice. This document and its contents are proprietary to Neuros Medical. No part of this manual may be reproduced, distributed, or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Neuros Medical Please read the complete documentation provided before you use the device. Copyright © Neuros Medical Inc. 2023 ALL RIGHTS RESERVED. The Altius System® is protected by several U.S. Patents. For an up-to date list of relevant patents and patent applications, visit our patents page: http://www.neurosmedical.com/patents LB-0199 X7 Document Number Revision ALTIUS PATIENT CONTROLLER AND BATTERY CHARGER MANUAL DCO NUMBER: 24-0010 RELEASE DATE: TBD Page 3 of 28 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Table of Contents 1. Explanation of Symbols ....................................................................................................................... 5 2. Introduction ......................................................................................................................................... 6 3. Warnings .............................................................................................................................................. 7 3.1. Warnings about Other Medical Treatments .............................................................................. 7 3.2. Caution and Warnings Associated With Battery Charger and Patient Controller Operation 8 4. Altius Patient Controller and Battery Charger Overview ................................................................. 8 4.1. Altius Patient Controller Overview ............................................................................................ 8 4.2. Altius Battery Charger Overview ............................................................................................. 10 5. Living with the Altius System ........................................................................................................... 10 5.1. General Expectations ................................................................................................................ 10 5.2. Effect on Your Activities ............................................................................................................ 10 5.3. Medications ................................................................................................................................ 10 5.3.1. Pain relief Medications ...................................................................................................... 10 5.3.2. General Medications .......................................................................................................... 10 5.4. The Importance of Your Patient ID Card ................................................................................. 11 6. Using Your Altius System - Patient Controller ............................................................................... 12 6.1. Using Your Patient Controller .................................................................................................. 12 6.2. Communicating with the Altius IPG ......................................................................................... 12 6.3. About Your Altius IPG Battery .................................................................................................. 13 6.4. Turning Treatment Off .............................................................................................................. 13 6.5. Starting a Treatment Session ................................................................................................... 14 6.6. Lock Out ..................................................................................................................................... 15 6.7. Audible Signals from your Patient Controller ......................................................................... 15 6.8. Understanding Battery Status .................................................................................................. 16 6.9. Altius Patient Controller Battery Replacement....................................................................... 16 7. Using Your Altius System - Battery Charger.................................................................................... 17 7.1. Battery Charger Description ..................................................................................................... 17 7.2. Importance of Charging Your Altius IPG ................................................................................. 18 LB-0199 X7 Document Number Revision ALTIUS PATIENT CONTROLLER AND BATTERY CHARGER MANUAL DCO NUMBER: 24-0010 RELEASE DATE: TBD Page 4 of 28 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document 7.3. Altius Battery Charger Features ............................................................................................... 19 7.4. To Prepare the Charger ............................................................................................................. 19 7.5. Charging Your Altius Generator .................................…

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Form: RFT-AMER-TCB-OP-19n Revision: 1 Page 1 of 1 Date: 1/25/2023 Attention: Application Examiner Re: Covered List, located at https://www.fcc.gov/supplychain/coveredlist and 47 CFR parts §2.903 and §2.911(d)(5)(ii) of the FCC rules Applicant: Neuros Medical, Inc FCC ID: 2BATK603 To whom it may concern, Neuros Medical, Inc (“Applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to 47 CFR part §2.903 of the FCC rules and does not originate directly or indirectly from any company named on the covered list located in the link above or any subsidiary or affiliate thereof. Applicant further certifies that, as of the date of the filing of the application, the Applicant is not identified on the Covered List as an entity producing “covered” equipment and is not a subsidiary or affiliate of any such entity pursuant to 47 CFR part §1.50002 and required by 47 CFR part §2.911(d)(5)(ii) of the FCC rules. Applicant further certifies that no Cybersecurity or anti-virus software produced or provided by Kaspersky Lab, Inc. or any of its successors and assignees, including equipment with integrated Kaspersky Lab, Inc. (or any of its successors and assignees) cybersecurity or anti-virus software is installed in the equipment being certified. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant and agree to immediately notify Intertek if there is any change in the status identified above. Raymond Zackowski Principal Systems Engineer Neuros Medical, Inc 01/Oct/2024

NeurosMedical.com Form: RFT-AMER-TCB-OP-19o Revision: 1 Page 1 of 1 Date: 1/ 25/2023 Attention: Application Examiner Re: Certification designating a U.S. agent for service of process pursuant to 47 CFR part §2.911(d)(7) of the FCC rules To whom it may concern, This letter is to certify that Neuros Medical, Inc. (“Applicant”) accepts responsibilities to act as its own agent pursuant to 47 CFR part §2.911(d)(7) of the FCC rules for service of process. I consent to the obligation to accept service of process on behalf of the applicant in regard to the FCC ID designated below. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant. I further acknowledge the requirement to maintain an agent extends for no less than one year after the termination of all marketing and importation or the conclusion of and commission-related proceeding involving the equipment and agree to immediately notify the FCC and Intertek if there is any change in the status identified above. Applicant Company Name : Neuros Medical, Inc. Contact Name : Raymond M Zackowski Address : 26800 Aliso Viejo Pkwy, Suite 250, Aliso Viejo, CA, USA, 92656 Telephone No : 440-951-2565 ext. 125 Email : [email protected] FCC ID : 2BATK603 Applicant FRN : 0033629213 Signature: ____________________________________ Date: ___26-Jun-2024_________________________________

Attention: Application Examiner Re: Request for confidentiality Applicant: Neuros Medical, Inc. FCC ID: 2BATK601, 2BATK603, 2BATK604, 2BATK606 To whom it may concern, Request is hereby submitted by NEUROS MEDICAL to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential: • Schematics • Detailed Block diagrams • Detailed Operational/Functional Description Neuros Medical, Inc. has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. The sale of the device may be subject to non-disclosure of terms. The fee for confidentiality has been submitted along with the fee for certification. If you have questions or need further information, please contact the undersigned. Sincerely, Raymond M Zackowski Principal Systems Engineer Neuros Medical, Inc.

2/07/24 Intertek Testing Services NA Ltd. 70 Codman Hill Road Boxborough, MA 01719 Subject: Limited Agency Agreement Neuros Medical, Inc. FCC ID: 2BATK601, 2BATK603, 2BATK604, 2BATK606 To Whom It May Concern: We, Neuros Medical, Inc., hereby authorized Jean Servais of Intertek Testing Services NA Ltd. to act as our Agent for the purpose of preparing application for FCC ID numbers BATK601, 2BATK603, 2BATK604, 2BATK606 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 2/7/2024. The Limited Agency Agreement expires on 10/07/2024, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, Raymond M Zackowski Principal Systems Engineer Neuros Medical, Inc. Email: [email protected]

NeurosMedical.com Attention: Application Examiner Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Re: Applicant Authorization Signature Applicant FRN: 0033629213 To whom it may concern, I Nemath Syed-Shah authorize Raymond Zackowski to sign the application documents for the following FCC ID’s: 2BATK601, 2BATK603, 2BATK604, 2BATK606. Thank you for your attention to …

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