2A3S8-MODEL20010The NINA is a medical device that is an external pulse generator for nerve stimulation.

Instructions for Use CAUTION: Investigational Device. Limited by United States law to investigational use. 1 Table of Contents DESCRIPTION ......................................................................................1 INTENDED USE / INDICATIONS FOR USE ..............................2 CONTRAINDICATIONS ...................................................................2 WARNINGS...........................................................................................2 PRECAUTIONS ....................................................................................3 Unpack the NiNA System ...............................................................4 Charge NiNA ........................................................................................................................4 Pair NiNA with the NiNA App ....................................................................................5 Treatment Frequency ....................................................................................................5 Assemble and Prepare the NiNA System for Use .......................................6 Place the NiNA System On the Leg......................................................................6 Begin Treatment ...............................................................................................................8 During Treatment ..........................................................................................................10 After Treatment ................................................................................................................11 NiNA DISPLAY ...................................................................................13 MAINTAINING THE NINA SYSTEM ...........................................14 DISPOSAL ...........................................................................................14 TROUBLESHOOTING .....................................................................14 OPERATING AND STORAGE ENVIRONMENT ....................16 PRODUCT SPECIFICATIONS .....................................................16 ELECTROMAGNETIC COMPATIBILITY...................................17 FCC Caution ....................................................................................................................20 SYMBOLS GLOSSARY ..................................................................21 DESCRIPTION The EBT Medical Non-Invasive Neuromodulation Assistant (NiNA) uses transcutaneous electrical stimulation of the saphenous nerve to treat symptoms of overactive bladder. NiNA delivers mild, adjustable electrical stimulation pulses to the saphenous nerve just below the knee that help to restore the bladder-brain connection. The NiNA System ™ (Figure 1) consists of the rechargeable NiNA, Dock, Pad, and reusable Wrap that holds the Pad and NiNA in place on the inside of either leg just below the knee crease (Figure 2). The NiNA System treatment plan is self-administered in the home and has two stages: Restore and Maintain. During the Restore stage, the 30-minute treatment is performed once a day for the first 28 days. After 28 days, the treatment plan advances to the Maintain stage where the treatment frequency is decreased to three times per week for 30 minutes. The NiNA Care ™ App can be used to control NiNA and is designed to provide an enhanced therapy experience. It has additional features to support the use of the NiNA System including reminders for performing therapy, progress tracking, tutorials and checks for ensuring proper therapy delivery, educational content, and instructional videos. The NiNA App is available for Android and iOS users. Wrap Figure 1. The NiNA System consists of the rechargeable NiNA, Dock with Cable/ Adapter, Pad, and Wrap that holds NiNA and the Pad in place. Pad with LinerNiNADockAdapterCable 23 Do not charge the NiNA System in or near water as this could lead to electrical shock. Do not use the NiNA System while using any other electrical therapy device such as a TENS unit as this could cause interference with therapy or unintended stimulation of other areas. Do not use the NiNA System near metal as this could interfere with therapy or cause heating. Remove jewelry or any other metallic items near the treatment area. Do not use the NiNA System near X-ray, MRI, CT, or diathermy devices. These devices may alter the energy delivered by the NiNA System and/or cause tissue damage, severe injury, or burns. Do not use the NiNA System close to short wave or microwave therapy equipment (within three feet) which may produce variability in stimulation strength or output. Use only NiNA System components. Use of other components may cause allergic reactions and/or compromise or cause improper stimulation during treatment sessions. Do not use the NiNA System while exercising, cycling, driving, operating machinery, or during any other activity in which stimulation could result in the risk of injury. Discontinue use of the NiNA System if pain, skin irritation, or other adverse reactions occur. Use of the NiNA System over tattoos containing ferromagnetic compounds has not been studied. Do not modify, disassemble, crush, or use the NiNA System in any other way other than how described in the Instructions for Use. The NiNA System cannot be serviced or repaired. Do not attempt this yourself. PRECAUTIONS Use the NiNA System only at room temperature. Allow the NiNA System to acclimate for at least two hours if stored in hot or cold temperatures. Do not leave, store, or charge the NiNA System in direct sunlight, near a fire, or in any other high temperature environment. The NINA System and Pads are for a single-user only, do not share with others. Discontinue use of the Pad if it becomes dirty, contaminated, or loses its adhesive properties. These conditions could interfere with proper stimulation. INTENDED USE / INDICATIONS FOR USE The EBT Medical NiNA System is intended for the treatment of overactive bladder and as…

Text truncated - open the document above for the full version.

EBT Medical US, Inc. 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders March 14, 2022 Keystone Compliance 2320 Presidential Dr Suite 101 Durham, NC 27703 Subject:Limited Agency Agreement EBT Medical US, Inc. FCC ID: 2A3S8-MODEL20010 To Whom It May Concern: We, EBT Medical US, Inc., hereby authorize Joey Sullivan of Keystone Compl iance to act as our Agent for the purpose of preparing application for FCC ID number 2A3S8-MODEL20010 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is March 14 th , 2022. The Limited Agency Agreement expires on March 14 th , 2023, unless sooner terminated or extended by written notice to Keystone Compliance 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, Mike Labbe VP of Research and Development

EBT Medical US, Inc. 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders March 4, 2022 Attention: Application Examiner RE: Request for Confidentiality Applicant: EBT Medical US, Inc. FCC ID: 2A3S8-MODEL20010 To Whom It May Concern: Request is hereby submitted by EBT Medical US, Inc. 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 • Internal photos – The enclosure is permanently sealed and cannot be opened without rendering the device non-functional for its intended use. Additionally, re quest is hereby submitted by EBT Medical US, Inc. to withhold from public review for a period of 45 days from the date of the Grant of Equipment Authorization and prior to marketing, certain portions of the application for equipment cert if ication 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 confidential for a period of 45 days from the date of Authorization: • External photos • Test setup photos • User Manual Rationale for request for confidentiality: EBT Medical US, I nc. 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. Disclosure of the short-term confidential portions of this application during the period of importation and/or distribution would reveal key aspects of proprietary technology to competitors and diminish the value of our investment in research and development. If you have questions or need further information, please contact the undersigned. Sincerely, Mike Labbe VP of Research and Development EBT Medical US, Inc.

EBT Medical US, Inc. 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders External Photos External Photo ‐ Top View, LCD Display External Photo ‐ Top View EBT Medical US, Inc. 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders External Photo ‐ Angled Top View External Photo ‐ Side View, Top External Photo ‐ Side View, Bottom EBT Medical US, Inc. 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders External Photo ‐ Bottom View

VARIABLES DATA SHOWN PINK NOTES: VARIABLE DATA TO BE PRINTED BY NEXTERN USING RIBBON 1. D102840-001 LABEL MATERIAL WHITE PET / PERM / 55 THERMAL IMPRINT LAMINATE2. MUST PASS 60601 CLEANING AND DURABILITY TESTS 3. SHALL BE REMOVABLE ONLY WITH A TOOL OR BY APPRECIABLE 4. FORCE CLEANING TEST:5. MARKINGS RUBBED BY HAND, FIRST FOR 15 SEC. WITH A CLOTH RAG SOAKED WITH DISTILLED WATER, THEN FOR 15 SEC. WITH A CLOTH RAG SOAKED WITH ETHANOL 96%, AND THEN FOR 15 SEC. WITH A CLOTH RAG SOAKED WITH ISOPROPYL ALCOHOL. ADHESIVE LABELS ARE NOT TO HAVE WORKED LOOSE OR BECOME 6. CURLED AT THE EDGES AFTER CLEANING. MARKINGS TO BE SUFFICIANTLY DURABLE TO REMAIN CLEARLY 7. LEGIBLE. IMAGES SHOWN FOR REFERENCE ONLY. SEE ARTWORK FILE "101866-8. 001 03_14_22.AI" FOR ARTWORK DEFINITION. CENTER ARROW SHAPE TO BE CUT OUT SUCH THAT IT IS 9. REMOVABLE. REVISIONS REV.DESCRIPTIONECNDATEDRAWNCHECKED AINITIAL RELEASECO-225099/16/2021CNSK BARTWORK UPDATECO-2320411/24/2021CNSK CADDED FCC INFO, UPDATED NOTES, ADDED PANTONE CALLOUTSCO-2325712/9/2021CNNC C1ADDED ARROW CUT OUT NOTECO-235251/17/2022CNPC DUPDATED FCC ID TO ALL CAPSCO-240013/14/2022CNPC PART NUMBERDESCRIPTION 101866-001EBT - PG Label D C B A A B C D 1 2 3 4 5 6 7 8 8 7 6 5 4 3 2 1 EBT - PG Label 1 OF 1101866-001 ALL DIMENSIONS IN MM. TOLERANCE,EXCEPT AS NOTED: X.X = 0.4MM X.XX = 0.2MM X.XXX = 0.1MM ANGLE= 0.5 NOTICE OF PROPRIETARY INFORMATION: ALL INFORMATION CONTAINED HEREIN IS THE PROPRIETARY PROPERTY OF NEXTERN INC. WHEN FURNISHED WITH A PROPOSAL, THE RECIPIENT SHALL USE IT SOLELY TO EVALUATE THE PROPOSAL. WHEN FURNISHED TO A CUSTOMER, IT SHALL BE USED SOLELY FOR PURPOSES OF INSPECTION, INSTALLATION, OR MAINTENANCE. WHEN FURNISHED TO A SUPPLIER, IT SHALL BE USED SOLELY IN THE PERFORMANCE OF THE WORK CONTRACTED FOR OR BY NEXTERN INC. THE INFORMATION SHALL NOT BE USED OR DISCLOSED BY THE RECIPIENT FOR ANY OTHER PURPOSE WHATSOEVER. D www.nextern.com REV DOCUMENT NUMBER DESCRIPTION SHEETSIZESCALE NONE B DRAWN APPROVED DATE DATE 9/15/2021CN

EBT Medical, Inc. 34 Hayden Rowe, Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders ID Label and Location Figure 1 is a detailed image of the label for the Nina pulse generator. See Appendix A for the complete label specification. Figure 2 represents the location that the label will be placed on the bottom of the Nina pulse generator. Figure 1 – Detailed image of the Label with FCC ID number on it. Variable data is shown in pink. Label to be either primarily White or Purple. EBT Medical, Inc. 34 Hayden Rowe, Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders Figure 2 – Diagram of the Nina pulse generator. Location of the label on the device identified by location 1. 1 EBT Medical, Inc. 34 Hayden Rowe, Suite 154 Hopkinton, Massachusetts 01748 www.ebtmedical.com Reimagining the Treatment of Pelvic Health Disorders Appendix A The following attachment is the label specification. VARIABLES DATA SHOWN PINK NOTES: VARIABLE DATA TO BE PRINTED BY NEXTERN USING RIBBON 1. D102840-001 LABEL MATERIAL WHITE PET / PERM / 55 THERMAL IMPRINT LAMINATE2. MUST PASS 60601 CLEANING AND DURABILITY TESTS 3. SHALL BE REMOVABLE ONLY WITH A TOOL OR BY APPRECIABLE 4. FORCE CLEANING TEST:5. MARKINGS RUBBED BY HAND, FIRST FOR 15 SEC. WITH A CLOTH RAG SOAKED WITH DISTILLED WATER, THEN FOR 15 SEC. WITH A CLOTH RAG SOAKED WITH ETHANOL 96%, AND THEN FOR 15 SEC. WITH A CLOTH RAG SOAKED WITH ISOPROPYL ALCOHOL. ADHESIVE LABELS ARE NOT TO HAVE WORKED LOOSE OR BECOME 6. CURLED AT THE EDGES AFTER CLEANING. MARKINGS TO BE SUFFICIANTLY DURABLE TO REMAIN CLEARLY 7. LEGIBLE. IMAGES SHOWN FOR REFERENCE ONLY. SEE ARTWORK FILE "101866-8. 001 03_14_22.AI" FOR ARTWORK DEFINITION. CENTER ARROW SHAPE TO BE CUT OUT SUCH THAT IT IS 9. REMOVABLE. REVISIONS REV.DESCRIPTIONECNDATEDRAWNCHECKED AINITIAL RELEASECO-225099/16/2021CNSK BARTWORK UPDATECO-2320411/24/2021CNSK CADDED FCC INFO, UPDATED NOTES, ADDED PANTONE CALLOUTSCO-2325712/9/2021CNNC C1ADDED ARROW CUT OUT NOTECO-235251/17/2022CNPC DUPDATED FCC ID TO ALL CAPSCO-240013/14/2022CNPC PART NUMBERDESCRIPTION 101866-001EBT - PG Label D C B A A B C D 1 2 3 4 5 6 7 8 8 7 6 5 4 3 2 1 EBT - PG Label 1 OF 1101866-001 ALL DIMENSIONS IN MM. TOLERANCE,EXCEPT AS NOTED: X.X = 0.4MM X.XX = 0.2MM X.XXX = 0.1MM ANGLE= 0.5 NOTICE OF PROPRIETARY INFORMATION: ALL INFORMATION CONTAINED HEREIN IS THE PROPRIETARY PROPERTY OF NEXTERN INC. WHEN FURNISHED WITH A PROPOSAL, THE RECIPIENT SHALL USE IT SOLELY TO EVALUATE THE PROPOSAL. WHEN FURNISHED TO A CUSTOMER, IT SHALL BE USED SOLELY FOR PURPOSES OF INSPECTION, INSTALLATION, OR MAINTENANCE. WHEN FURNISHED TO A SUPPLIER, IT SHALL BE USED SOLELY IN THE PERFORMANCE OF THE WORK CONTRACTED FOR OR BY NEXTERN INC. THE INFORMATION SHALL NOT BE USED OR DISCLOSED BY THE RECIPIENT FOR ANY OTHER PURPOSE WHATSOEVER. D www.nextern.com REV DOCUMENT NUMBER DESCRIPTION SHEETSIZESCALE NONE B DRAWN APPROVED DATE DATE 9/15/2021CN

SAR Exclusion Report Applicant: EBT Medical US Inc Equipment Under Test: EBT Pulse Generator FCC ID: 2A3S8-MODEL20010 Applicable Standards: 47 CFR §§ 2.1093; FCC KDB 447498 D01 General RF Exposure Guidance v06 Report issued on: 28 April 2022 Result: Exempt Page 2 of 4 TABLE OF CONTENTS 1 GENERAL INFORMATION ............................................................................................................................................. 3 1.1 APPLICANT INFORMATION ............................................................................................................................................. 3 1.2 GENERAL INFORMATION OF EUT .................................................................................................................................. 3 1.3 OPERATING MODES AND CONDITIONS .......................................................................................................................... 3 2 SAR EXCLUSION CALCULATIONS ............................................................................................................................. 4 Page 3 of 4 1 General Information 1.1 Applicant Information Name: EBT Medical US Address: 34 Hayden Rowe Suite 154 City, State, Zip, Country: Hopkinton, MA 01748, USA 1.2 General Information of EUT Product Description: EBT Pulse Generator Frequency Range: 2402 - 2480 MHz Data Modes: GFSK (1M / 2M) Antenna: On-board dipole, +2.1 dBi Rated Voltage: 4Vdc 1.3 Operating Modes and Conditions Maximum measured conducted power levels were utilized for all calculations. Page 4 of 4 2 SAR Exclusion Calculations Input Select Units Unit correction Max Power: -3.42dBm0.454988060.455 Duty Cycle: 100.0% Min separation distance: 1mm1 Frequency, f: 2480MHz2480100 Value reference Number v10.455mW v21mm v31.575 a) Exclusion Calculation(1g):0.7165number Exclusion Calculation(10g):0.7165number Conclusions (Body): Conclusions (Extremity): Values used for Calculation For 100 MHz to 6 GHz and test separation distances ≤ 50 mm, the 1-g and 10-g SAR test exclusion thresholds are determined by the following: 447498 D01 General RF Exposure Guidance v06 SAR test exclusion calculations Section 4.3: General SAR test exclusion guidance / Section 4.3.1: Standalone SAR test exclusion considerations Reference number definition [max. power of channel, including tune-up tolerance, mW] 'Rounded to nearest mW [min. test separation distance, mm] 'Rounded to nearest mm [√f(GHz)] [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR, and ≤ 7.5 for 10-g extremity SAR, <== [v2 / v3] must be less than 3 <== [v2 / v3] must be less than 7.5 The EUT max power is BELOW the threshold. SAR Testing is NOT required for Body applications The EUT max power is BELOW the threshold. SAR Testing is NOT required for Extremity applications <== Source based time average duty cycle

Keystone Compliance, LLC 2320 Presidential Dr #101 Durham, NC 27703 Phone: 724-657-9940 Fax: 724-657-9920 EBT Medical US Inc 2107-111C-3 FCC Accreditation Designation Number: US1308 Innovation, Science and Economic Development Canada Accreditation Site Number: US0232 Certificate #3293.03 This report must not be used by the client to claim product certification, approval, or endorsement by A2LA, NIST, or any agency Federal Government. CONTROLLED DATA PAGE 2 OF 65 FCC Test Report 2107-111C-3 Rev. C Test Standards: FCC Rule Part: 15.247 & ISED Canada Radio Standards Specification: RSS-247 For EBT Medical US Inc 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 On EBT Pulse Generator FCC ID: 2A3S8-MODEL20010 Model Number: N/A ; Part Number: N/A ; Serial Number: PG-D0010 and PG-D0011 Performed By: Keystone Compliance, LLC. 2320 Presidential Drive, Suite 101 Durham, NC 27703 Keystone Compliance, LLC. does hereby certify that all inspections and tests have been performed in accordance with the documents referenced herein with exceptions as noted in this report. The results in this report pertain to the specified equipment tested. This report shall not be reproduced, except in full, without the written authorization of Keystone Compliance, LLC. Prepared By: Date: 4/28/2022 Maria Rodgers, Report Writer Approved By: Date: 4/28/2022 Sam Mastovich, General Manager Approved By: Date: 4/28/2022 Joey Sullivan, Quality Manager Testing Services www.keystonecompliance.com REPORT NO.: 2107-111C-3 REVISION: C FCC TE S T RE P O R T FO R EBT MEDICAL US INC CONTROLLED DATA PAGE 3 OF 65 2320 Presidential Dr, Suite 101 ▪ Durham, NC 27703 Ph.: 919-296-0098 www.keystonecompliance.com Document History Revision Issue Date Description of Modifications Revised By Approved By N/C 11/22/2021 Initial release N/A A.S. A 11/22/2021 Revised company name/address HS AS B 3/9/2022 Revised to remove confidential pictures MR SM C 4/28/2022 Revised test set up block diagram MR SM REPORT NO.: 2107-111C-3 REVISION: C FCC TE S T RE P O R T FO R EBT MEDICAL US INC CONTROLLED DATA PAGE 4 OF 65 2320 Presidential Dr, Suite 101 ▪ Durham, NC 27703 Ph.: 919-296-0098 www.keystonecompliance.com Client Information Purchase Order Quote Number EUT Arrival Date A000966904 2107-111C-3 9/20/2021 -- Recieved in good conditionRecieved in good condition Company Name Address City, State Zip Nextern 1185 Birch Lake Boulevard North White Bear Lake, MN 55110 EBT Medical US Inc 34 Hayden Rowe Suite 154 Hopkinton, Massachusetts 01748 Contact Name Phone Email Jon Lawson (651) 203-2108 [email protected] Test Facility Information Test Laboratory Address City, State, Zip Code Phone Web Site Keystone Compliance, LLC. 2320 Presidential Drive, Suite 101 Durham, NC 27703 (919) 296-0098 www.keystonecompliance.com Contact Name Title E-Mail Address Al Servais Lab Manager [email protected] REPORT NO.: 2107-111C-3 REVISION: C FCC TE S T RE P O R T FO R EBT MEDICAL US INC CONTROLLED DATA PAGE 5 OF 65 2320 Presidential Dr, Suite 101 ▪ Durham, NC 27703 Ph.: 919-296-0098 www.keystonecompliance.com TABLE OF CONTENTS Introduction ..................................................................................................................................................................... 7 Acronyms and Abbreviations ........................................................................................................................................... 8 Configuration ................................................................................................................................................................... 9 Section 1 – Test Conditions and Equipment ................................................................................................................... 11 1.1 Instrumentation and Equipment ................................................................................................................. 11 1.2 Tolerances ................................................................................................................................................... 11 1.3 Test Methodology and Considerations ........................................................................................................ 11 1.4 Radiated Emissions Test Description ........................................................................................................... 12 1.4.1 Semi-Anechoic Chamber Test Site .............................................................................................. 12 1.5 Conducted Emissions Test Description ........................................................................................................ 13 1.5.1 Semi-Anechoic Chamber Test Site .............................................................................................. 13 Section 2 – References ................................................................................................................................................... 14 2.1 Applicable Specifications ............................................................................................................................. 14 Section 3 – Test Equipment ............................................................................................................................................ 15 3.1 Test Equipment ........................................................................................................................................... 15 Section 4 – Summary of Tests ........................................................................................................................................ 17 4.1 Antenna Requiremnt - FCC: 15.203 ............................................................................................................. 17 4.2 Power Line Conducted Emissions - FCC: 15.207, ISED Canada: RSS-Gen 8.8 ................................................. 17 4.2.1 Measurement Procedure ..........................…

Text truncated - open the document above for the full version.

TEST SETUP PHOTOS Conducted Emissions Conducted Emissions Radiated Emissions Radiated Emissions Radiated Emissions Radiated Emissions