2AEEGSMedical Device

AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 1 Neurostimulator Implant Manual Rechargeable | Model 5101 Rx only English Axonics® and Axonics Sacral Neuromodulation System® are trademarks of Axonics, Inc., registered or pending registration in the U.S. and other countries. Axonics, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonics.com Tel. +1-(877) 929-6642 Fax +1-(949) 396-6321 AXONICS SNM SYSTEM® – Neurostimulator | Rechargeable, Model 5101 Page 14 WIRELESS COMMUNICATION Model: 5101 FCC ID: 2AEEGS IC: 20225-S FCC Compliance This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation This transmitter is authorised by rule under the Medical Device Radio Communication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radio Communication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. IC Compliance This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device. FCC and IC Compliance This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. Note: Changes and modifications to the Neurostimulator are not authorised by Axonics and could void FCC and IC certification and negate the user’s authority to use the product. Quality of Wireless Service This device operates in the 402-405 MHz frequency and the maximum effective radiated power of the Neurostimulator communication is below the limit of 25 μW ERP/EIRP as specified in EU: EN ETSI 301-839 and USA: FCC 47 CFR Part 95; Subpart I. The Remote Control, Clinician Programmer or Charger must be within 1 meter from the implant for successful communication. Wireless Security The Neurostimulator can only communicate with a single Remote Control that is paired to it using the Clinician Programmer. Any Axonics Clinician Programmer or Charger can communicate with a Neurostimulator. Additional mechanisms exist to ensure the integrity of radio data. AXONICS SNM SYSTEM® – Neurostimulator | Rechargeable, Model 5101 Page 15 CUSTOMER SERVICE For questions regarding the Axonics SNM System, call our Customer Support Center toll-free at +1-877-929-6642. Additional information and product manuals can be found at our website: www.axonics.com Adverse Event Reporting In case of any serious incident related to the product, please report to Axonics (+1-877-929-6642) as well as the competent authority of your state, which can be found here: https://www.ema.europa.eu/en/partners-networks/eu-partners/eu- member-states/national-competent-authorities-human. Emergo Europe B.V. Prinsessegracht 20 2514 AP The Hague The Netherlands MedEnvoy Global B.V. The Hague Zug Branch Office Gotthardstrasse 28 6302 Zug Emergo Consulting (UK) Limited c/o Cr360 – UL International, Compass House, Vision Park Histon, Cambridge CB24 9BZ, United Kingdom 2022-05 All Rights Reserved. Copyright 2022. Axonics, Inc. 110-0290-101 Rev A

Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: ________________ Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Type of Confidentiality Requested Exhibit Type ☐Short Term☐Permanent Block Diagrams ☐Short Term External Photos ☐Short Term☐Permanent* Internal Photos ☐Short Term☐Permanent Operation Description ☐Short Term☐Permanent Parts List/BOM ☐Short Term☐Permanent Schematics ☐Short Term Test Setup Photos ☐Short Term☐Permanent* User manual *Requires further justification before permanent confidentiality will be allowed. The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: Pursuant to DA04-1705 June 15, 2004 of the Commission’s public notice, we also request temporary confidential treatment of information accompanying this application as outlined below for an initial period of ____________ days. Sincerely, Client’s signature: ________________________________ Client’s name & title: _____________________________ Contact information / address:

External Photos Axonics Modulation Technologies, Inc. Implantable Pulse Generator (IPG) Model: 5101 IC: 20225-S Front View Back View Top View Bottom View Left View Right View

IC: 20225-S FCC ID: 2AEEGS Neuros�mulator | R20 AXONICS SNM SYSTEM™ Axonics, Inc. 26 Technology Drive Irvine, California 92618 USA 57 kPa 106 kPa 15% 95% -10°C 55°C Rx ONLY (170-0138-001rB) 3 2 1 0 + 0 0 - 3 2 1 0 0 mA 210 μs 14 Hz 0 Model: 5101 1201 + h�p://www.axonics.com/eIFU D C B A A B C D 1 2 3 4 5 6 7 8 8 7 6 5 4 3 2 1 1

Internal Photos Axonics Modulation Technologies, Inc. Implantable Pulse Generator (IPG) Model: 5101 IC: 20255-S Front side Back side

Phone: +1 (949) 393-1123 Web: www.vista-compliance.com Email: [email protected] SAR Exposure Report Test Report Number AXN-22061451-LC-FCC-SAR Exclusion FCC ID 2AEEGS Applicant Axonics Modulation Technologies, Inc. Applicant Address 7575 Irvine Center Drive Suite 200, Irvine, CA 92618 Product Name Implantable Pulse Generator (IPG) Model (s) 5101 Date of Receipt 10/10/2022 Date of Test 10/10/2022- 10/13/2022 Report Issue Date 10/21/2022 Test Standards 47 CFR §2.1093 447498 D04 Interim General RF Exposure Guidance v01 Test Result PASS Issued by: Vista Compliance Laboratories 1261 Puerta Del Sol, San Clemente, CA 92673 USA www.vista-compliance.com Devin Tai (Test Engineer) David Zhang (Technical Manager) This report is for the exclusive use of the applicant. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. Note that the results contained in this report pertain only to the test samples identified herein, and the results relate only to the items tested and the results that were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested and the results thereof based upon the information provided to us. The applicant has 60 days from date of issuance of this report to notify us of any material error or omission. Failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. The report must not be used by the client to claim product certification, approval, or endorsement by any government agencies. This report is not to be reproduced by any means except in full and in any case not without the written approval of Vista Laboratories. Report# AXN-22061451-LC-FCC-SAR Exclusion Page 2 of 7 REVISION HISTORY Report Number Version Description Issued Date AXN-22061451-LC-FCC-SAR Exclusion 01 Initial report 10/21/2022 Report# AXN-22061451-LC-FCC-SAR Exclusion Page 3 of 7 TABLE OF CONTENTS 1 GENERAL INFORMATION ..................................................................................................................................... 4 1.1 Applicant .......................................................................................................................................................... 4 1.2 Product information ...................................................................................................................................... 4 1.3 Test standard and method .......................................................................................................................... 5 2 TEST SITE INFORMATION ..................................................................................................................................... 5 3 SAR EVALUATION ................................................................................................................................................... 6 3.1 Test Exemption .................................................................................................................................................. 6 4 SAR TEST EXCLUSION THRESHOLD RESULTS ................................................................................................. 7 Report# AXN-22061451-LC-FCC-SAR Exclusion Page 4 of 7 1 General Information 1.1 Applicant Applicant Axonics Modulation Technologies, Inc. Applicant address 7575 Irvine Center Drive Suite 200, Irvine, CA 92618 Manufacturer Axonics Modulation Technologies, Inc. Manufacturer Address 7575 Irvine Center Drive Suite 200, Irvine, CA 92618 1.2 Product information Product Name Implantable Pulse Generator (IPG) Model Number 5101 Family Models N/A Serial Number AX9H150423 Frequency Band MedRadio (MICS) 402-405 MHz, 300KHz channel spacing Type of modulation 2-FSK Equipment Type Medical Devices Equipment Class TNT Radio type MedRadio (MICS), implant Antenna Information Integral Antenna Clock Frequencies N/A Input Power Internal battery 3.65V (nominal) Power Adapter Manufacturer/Model N/A Power Adapter SN N/A Hardware version N/A Software version N/A Additional Info N/A Report# AXN-22061451-LC-FCC-SAR Exclusion Page 5 of 7 1.3 Test standard and method Test standard 47 CFR §1.1310 47 CFR §2.1093 Test method 47 CFR §1.1310 47 CFR §2.1093 447498 D04 Interim General RF Exposure Guidance v01 2 Test Site Information Lab performing tests Vista Laboratories, Inc. Lab Address 1261 Puerta Del Sol, San Clemente, CA 92673 USA Phone Number +1 (949) 393-1123 Website www.vista-compliance.com Test Condition Temperature Humidity Atmospheric Pressure RF Testing 23.2°C 57.5% 996 mbar Radiated Emission Testing 23.2°C 57.5% 996 mbar Report# AXN-22061451-LC-FCC-SAR Exclusion Page 6 of 7 3 SAR Evaluation 3.1 Test Exemption Per KDB 447498 D04 Interim General RF Exposure Guidance v01 1. 1-mW Test Exemption Per § 1.1307(b)(3)(i)(A), a single RF source is exempt RF device (from the requirement to show data demonstrating compliance to RF exposure limits, as previously mentioned) if the available maximum time-averaged power is no more than 1 mW, regardless of separation distance. This exemption applies to all operating configurations and exposure conditions, for the frequency range 100 kHz to 100 GHz, regardless of fixed, mobile, or portable device exposure conditions. This is a st…

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Phone: +1 (949) 393-1123 Web: www.vista-compliance.com Email: [email protected] FCC ISED RF Test Report Test Report Number AXN-22061451-LC-FCC IC-TNT FCC ID 2AEEGS IC Applicant 20225-S Axonics Modulation Technologies, Inc. Applicant Address 7575 Irvine Center Drive Suite 200, Irvine, CA 92618 Product Name Implantable Pulse Generator (IPG) Model (s) 5101 Date of Receipt 10/10/2022 Date of Test 10/10/2022- 10/13/2022 Report Issue Date 10/21/2022 Test Standards 47 CFR Part 95 Subpart I RSS 243 Issue3, February 2010 Test Result PASS Issued by: Vista Compliance Laboratories 1261 Puerta Del Sol, San Clemente, CA 92673 USA www.vista-compliance.com Devin Tai (Test Engineer) David Zhang (Technical Manager) This report is for the exclusive use of the applicant. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. Note that the results contained in this report pertain only to the test samples identified herein, and the results relate only to the items tested and the results that were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested and the results thereof based upon the information provided to us. The applicant has 60 days from date of issuance of this report to notify us of any material error or omission. Failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. The report must not be used by the client to claim product certification, approval, or endorsement by any government agencies. This report is not to be reproduced by any means except in full and in any case not without the written approval of Vista Laboratories. Report# AXN-22061451-LC-FCC IC-TNT Page 2 of 72 REVISION HISTORY Report Number Version Description Issued Date AXN-22061451-LC-FCC IC-TNT 01 Initial report 10/21/2022 Report# AXN-22061451-LC-FCC IC-TNT Page 3 of 72 TABLE OF CONTENTS 1 TEST SUMMARY ...................................................................................................................................................... 4 2 GENERAL INFORMATION ..................................................................................................................................... 5 2.1 Applicant .......................................................................................................................................................... 5 2.2 Product information ...................................................................................................................................... 5 2.3 Test standard and method .......................................................................................................................... 5 3 TEST SITE INFORMATION ..................................................................................................................................... 6 4 MODIFICATION OF EUT / DEVIATIONS FROM STANDARDS ....................................................................... 6 5 TEST CONFIGURATION AND OPERATION ....................................................................................................... 6 5.1 EUT Test Configuration ................................................................................................................................. 6 5.2 Supporting Equipment ................................................................................................................................. 7 6 UNCERTAINTY OF MEASUREMENT ................................................................................................................... 7 7 TEST RESULTS .......................................................................................................................................................... 8 7.1 Frequency stability......................................................................................................................................... 8 7.2 Emission Bandwidth (20dB bandwidth) .................................................................................................. 11 7.3 Occupied Bandwidth (99%) ........................................................................................................................ 13 7.4 Emission Mask .............................................................................................................................................. 15 7.5 Transmitter conducted output power ..................................................................................................... 19 7.6 MedRadio equivalent isotropic radiated power (M-EIRP) ................................................................... 21 7.7 Transmitter Unwanted Spurious Emissions .......................................................................................... 25 7.8 Conducted Spurious Emissions ................................................................................................................ 63 7.9 Receiver Spurious Emissions ..................................................................................................................... 65 8 EUT AND TEST SETUP PHOTOSF ...................................................................................................................... 71 9 TEST INSTRUMENT …

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Antenna Info Axonics Modulation Technologies, Inc. Implantable Pulse Generator (IPG) Model: 5101 FCC ID: 2AEEGS 1. An Axonics in house custom cooper loop antenna printed on PCB assembly (PCBA) board and connected directly to the intentional radiator. Access to antenna connections of the intentional radiator are prohibited by the enclosure. 2. The approximate gain of the 402-405MHz loop antenna is -23 dBi. 3. The device, incorporates a permanently attached antenna.

Radiated Emission Test below 1GHz Front View Radiated Emission Test below 1GHz Rear View Radiated Emission Test above 1G Front View Radiated Emission Test above 1GHz Rear View Close-up View