FCC ID: 2AEEGS Medical Device

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 | Recharge-Free, Model 4101 Page 1 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 400.150406.000 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 400.150406.000 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 users 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 W 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 14 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 AXONICS SNM SYSTEM Neurostimulator | Rechargeable, Model 5101 Page 15

8 7 6 5 4 3 2 1 D C B A AXONICS SNM SYSTEM Neurosmulator | R20 Model: 5101 IC: 20225-S FCC ID: 2AEEGS

1201 hp://www.axonics.com/eIFU 55C 95%

106 kPa

-10C 15%

57 kPa Rx ONLY 0 mA 210 s 14 Hz 3 2 1 0 3 2 1 0

+ 0 0 -

0 Axonics, Inc. 26 Technology Drive Irvine, California 92618 USA

(170-0138-001rB) D C B A 8 7 6 1 5 4 3 2 1

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 Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:

Permanent Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent*

Permanent Permanent Permanent Exhibit Type Block Diagrams External Photos Internal Photos Operation Description Parts List/BOM Schematics Test Setup Photos User manual Permanent*

*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 Commissions public notice, we also request temporary confidential treatment of information accompanying this application as outlined below for an initial period of ____________ days. Sincerely, Clients signature: ________________________________ Clients name & title: _____________________________ Contact information / address: