2BATK601Altius IPG

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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VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Altius System ® Patient Manual Caution: Federal (US) law restricts this device to sale by or on the order of a physician LB-0196 Rev X8 LB-0196 X8 Document Number Revision ALTIUS SYSTEM PATIENT MANUAL DCO NUMBER: 24-0010 RELEASE DATE: TBD Page 2 of 27 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-0196 X8 Document Number Revision ALTIUS SYSTEM PATIENT MANUAL DCO NUMBER: 24-0010 RELEASE DATE: TBD Page 3 of 27 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. 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) .................. 14 8.2. Altius Patient Controller Overview .......................................................................................... 14 8.3. Altius Battery Charger Overview ............................................................................................. 15 8.4. Altius Programmer System Overview ..................................................................................... 16 9. Following Implantation Surgery ...................................................................................................... 16 10. Living with the Altius System ........................................................................................................... 17 10.1. General Expectations ............................................................................................................ 17 10.2. Effect on Your Activities ........................................................................................................ 17 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 ............................................................................ 20 Appendix II: Replaceable Parts & Cables ................................................................................................. 22 LB-0196 X8 Document Number Revision ALTIUS SYSTEM PATIENT MANUAL DCO NUMBER: 24-0010 RELEASE DATE: TBD Page 4 of 27 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Appendix III: Wireless Specifications of the Altius System .................................................................... 23 Appendix IV: Electromagnetic Interference Information ...................................................................... 24 Appendix V: Federal Communications Commission (FCC) ................................…

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VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Altius System ® Implantable Pulse Generator and Cuff Electrode Lead Implant Manual and Instructions for Use Caution: Federal (US) law restricts this device to sale by or on the order of a physician. LB-0198 Rev X7 LB-0198 X6 Document Number Revision ALTIUS SYSTEM IPG AND CUFF ELECTRODE IMPLANT MANUAL AND INSTRUCTIONS FOR USE DCO NUMBER: 23-0116 RELEASE DATE: TBD Page 2 of 29 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-0198 X6 Document Number Revision ALTIUS SYSTEM IPG AND CUFF ELECTRODE IMPLANT MANUAL AND INSTRUCTIONS FOR USE DCO NUMBER: 23-0116 RELEASE DATE: TBD Page 3 of 29 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document Table of Contents 1. Explanation of Symbols ........................................................................................................ 5 2. Altius System Overview ........................................................................................................ 7 2.1. Description of Altius High Frequency Nerve Block System ........................................ 7 2.2. Altius System IPG Physical Characteristics ................................................................. 8 2.3. Altius System Nerve Cuff Electrode Physical Characteristics ....................................10 2.4. Altius System IPG Rechargeable Battery Behavior ....................................................11 2.5. Altius System IPG Battery Life ...................................................................................11 2.6. Altius system programming settings .........................................................................12 3. Experience and training ......................................................................................................13 4. Handling .............................................................................................................................13 4.1 General ...........................................................................................................................13 4.2 Handling during Surgical Implant ..................................................................................13 4.3 Storage and Handling .....................................................................................................14 4.4 Packaging Information ...................................................................................................14 4.4 Re-sterilization and Reuse .............................................................................................15 5. Device Implantation ............................................................................................................15 5.1. General Considerations .............................................................................................15 5.1.1. Patient Pre-operative preparation .........................................................................16 5.1.2. Patient Preparation ...............................................................................................16 5.2. Cuff Electrode Implantation.......................................................................................17 5.2.1. Cuff Electrode Placement ......................................................................................17 5.2.2. Anchoring the Cuff Electrode .................................................................................18 5.3. IPG Implantation and Cuff Electrode Connection ......................................................19 5.3.1. Tunneling Cuff Electrode Lead Cable to Generator Pocket .......................................19 5.3.2. Connecting and Implanting the Generator ..............................................................20 5.3.3. Completing the Implant Procedure ........................................................................21 5.3.4. Post-op patient care & Antibiotics ..........................................................................22 LB-0198 X6 Document Number Revision ALTIUS SYSTEM IPG AND CUFF ELECTRODE IMPLANT MANUAL AND INSTRUCTIONS FOR USE DCO NUMBER: 23-0116 RELEASE DATE: TBD Page 4 of 29 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document 6. Device Explantation ............................................................................................................22 6.1. Explanting or Replacing the Neuros Altius Generator ...............................................22 6.2. Explanting or Replacing the Cuff Electrode ...............................................................23 Appendix I: Replaceable Parts & Cables .......................................................................................25 Appendix II: Wireless Specifications of the Altius System .............................................................26 Appendix III: Electromagnetic Interference Information ..............................................................27 Refer to the Prescriber manual for ind…

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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: 2BATK601 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 : 2BATK601 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 this matter. Sincerely, Nemath Syed-Shah Sr. Manager, R&D Neuros Medical 26800 Aliso Viejo Pkwy, Suite 250 Aliso Viejo, CA 92656

External Photos Insert a sufficient number of photographs to clearly show the exterior appearance, the construction, the component placement on the chassis, and the chassis assembly per Section 2.1033. Altius IPG: Altius IPG External Photo, Front Altius IPG External Photo, Back Altius IPG External Photo, Top looking down

System Name: Altius System Unit Name: Altius IPG Label Description: Draft Altius IPG Blister Package Label Label Description: Draft Altius IPG Box Package Label Label Description: Draft Altius IPG Box Label Placement

Attention: Application Examiner Re: Justification required per 47 CFR 15.19(a)(5) Applicant: Neuros Medical, Inc. FCC ID: 2BATK601 To whom it may concern, The product (Altius IPG) is an Active Implantable device. It is packaged and sterilized. The packaging system of the product ensures that it remains sterile until is delivered to a healthcare facility where it may then be implanted in someone. Therefore, it is impractical to apply the language required by 47 CFR 15.19(a)(3) on the Altius IPG. Once implanted in the patient, the label and packaging is then disposed of by the healthcare facility and the patient never sees the packaging of the Altius IPG. Therefore, it is impractical to apply the language required by 47 CFR 15.19(a)(3) on the packaging of the Altius IPG. The User Manual, Neuros Document LB-0196 (Altius ® Direct Electrical Nerve Stimulation System Patient Manual) does contain the language required by 47 CFR 15.19(a)(3). This language does meet the standard and its intent of informing the user. Sincerely, Raymond M Zackowski Principal Systems Engineer Neuros Medical, Inc.

Internal Photos A sufficient number of photographs to clearly show construction, component placement, chassis assembly per Section 2.1033. Altius IPG Photos: IPG Internal Photo, PCBA in Manufactured Configuration, prior to Installation Top of PCBA, - Main Board (Center) - Secondary Board (Right) IPG Internal Photo, PCBA in Manufactured Configuration, prior to Installation Bottom of PCBA - Main Board (Center) - Secondary Board (Left) IPG Internal model, showing connections to Charge Coil, IPG Main board, Secondary board not pictured IPG Internal Photo, Comm Coil Connection to PCBA, Secondary Board IPG Internal Photo, Comm Coil placed over PCBA, Secondary Board Secondary Board is then connected to the main board, shown below Charge Coil Connection IPG Internal Photo, PCBA, Secondary Board mated to Main Board - Flex board on upper left of Main Board connects through a thruhole to the Charge Coil IPG Internal Photo, PCBA, Main Board showing connection to thru-hole for Charger IPG Internal Photo, PCBA, Secondary Board Mounted to main board in basket, with battery Charge Coil Connection thru-hole Charge Coil Connection thru-hole Charge Coil Connection thru-hole IPG Internal Photo, Charge Coil in Epoxy Header Charge Coil Connection to PCBA through hole connections IPG Internal Photo, Charge Coil in Epoxy Header, showing thru hole connection

Neuro Medical, Inc. SAR Test Exclusion Report SCOPE OF WORK SAR Test Exclusion Report of the Wireless Charger of the Altius system REPORT NUMBER 105246853BOX-011d.1 ISSUE DATE [REVISED DATE] July 26, 2023 July 24, 2024 DOCUMENT CONTROL NUMBER Non-Specific Radio Report Shell Rev. October 2022 © 2022 INTERTEK Non-Specific Radio Report Shell Rev. October 2022 Page 2 of 8 Client: Neuros Medical, Inc. – Model: Wireless Charger of the Altius system SAR TEST EXCLUSION REPORT (FULL COMPLIANCE) Report Number: 105246853BOX-011d.1 Project Number: G105246853 Report Issue Date: July 26, 2023 Report Revision Date: July 24, 2024 Model(s) Tested: Wireless Charger of the Altius system Model(s) Partially Tested: None Model(s) Not Tested but declared equivalent by the client: None Standards: KDB 447498 D01 General RF Exposure Guidance v06 Tested by: Client: Intertek 70 Codman Hill Road Boxborough, MA 01719 USA Neuros Medical Inc 35010 Chardon Road, Suite 210 Willoughby, OH 44094 USA Report prepared by Report reviewed by Kouma Sinn / Senior EMC Staff Engineer Vathana Ven / Senior EMC Staff Engineer This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Report Number: 105246853BOX-011d.1 Issued: 07/26/2023 Revised: 07/24/2024 Non-Specific Radio Report Shell Rev. October 2022 Page 3 of 8 Client: Neuros Medical, Inc. – Model: Wireless Charger of the Altius system Table of Contents 1 Introduction and Conclusion .............................................................................................................. 4 2 Test Summary ...................................................................................................................................... 4 3 Client Information ................................................................................................................................ 5 4 Description of Equipment Under Test and Variant Models ............................................................. 5 5 SAR Test Exclusion .............................................…

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