2BH4M-10102Implantable Neurostimulator

Instructions for use Enterra Ascent ® Rx only Humanitarian Device: Authorized by Federal law for use in the treatment of chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 years and above. The effectiveness of this device for this use has not been demonstrated. Table of contents Table of contents Indications ...............................................................................4 Contraindications .................................................................5 Warnings ..................................................................................6 Effects on other implanted devices .................................10 Precautions ...........................................................................12 Use in specific populations .................................................12 Physician training .....................................................................12 Packaging and sterilization ..................................................12 System implant .........................................................................13 Clinician programming ..........................................................17 Patient activities ........................................................................18 Hospital or medical environment .....................................19 Component disposal ........................................................20 Individualization of treatment ........................................21 Patient selection .....................................................................21 Adverse events summary .................................................21 Patient counseling information .........................................23 Appendix A: Enterra Therapy clinical studies ............24 World Wide Anti-Vomiting Electrical Stimulation Study (WAVESS) Contraindications ..................................24 WAVESS Compassionate Use study (WCU) ................30 Compassionate Use Electrical Stimulation Study .....33 (CUESS) WAVESS results .........................................................................36 Information available for the system: Product manuals, such as programming guides, and implant manuals provide device descriptions, package contents, device specifications, product-specific warnings and precautions, and instructions for use. The clinical summary provides information about the clinical study results for the neurostimulation system. Table of contents Appendix B: Electromagnetic interference ...............44 Contraindications ...................................................................44 Warnings......................................................................................46 Precautions ................................................................................51 Notes .............................................................................................54 Appendix C: Electromagnetic compatibility declaration ............................................................................56 Wireless Specifications and Safety ...................................57 Appendix D: Enterra Ascent Neurostimulator model 10102 communications regulations ...............61 United States Compliance ...................................................61 Appendix E: Cybersecurity ..................................................63 Appendix F: MRI Guidelines for Physicians ....................71 Appendix G: On/Off Instructions for Enterra Entrust Clinician Programmer ..........................................................80 Enterra Medical Neurostimulation System limited warranty 2 (U.S. Customers Only) ..................................84 Enterra Ascent ® | Instructions for Use | 2026-06 4 Indications Indications The Enterra Ascent ® System for Gastric Electrical Stimulation (GES) is indicated for the treatment of chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 years and above. Humanitarian Device: Authorized by Federal law for use in the treatment of chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 years and above. The effectiveness of this device for this use has not been demonstrated. Contraindications The Enterra Ascent System is contraindicated in patients if their doctor determines they are not a candidate for the surgical procedure and/or anesthesia because of physical or mental conditions. After implantation of any Enterra System component, the following contraindications apply: Enterra Ascent ® | Instructions for Use | 2026-06 5 Contraindications Diathermy - Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Refer to Appendix B: Electromagnetic interference on page 44 for more information. Patients with the Enterra Ascent System can safely have MRI examinations of some body parts under certain conditions. Consult your doctor if you have any questions. Enterra Ascent ® | Instructions for Use | 2026-06 6 Warnings Use as indicated and instructed - Read all information available for the system. Contact Enterra Medical for issues with device or package labels. Only use products for the indicated therapy and indicated populations. The consequences of using products for uses other than indicated and instructed are unknown. No claims of safety or efficacy are made with regard to the use of products for non-indicated or non-instructed uses. Bowel obstruction/perforation - The leads can become entangled with or erode into the bowel, whi…

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Patient Therapy Guide Enterra Ascent ® Gastric Electrical Stimulation System Rx only Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 years and above. The effectiveness of this device for this use has not been demonstrated. Enterra Ascent ® | Patient Therapy Guide | 2026-06 2 Doctor visits and when to call your doctor Always inform any health care personnel that you have an implanted neurostimulation system. It is important that you keep all your doctor appointments. Your doctor may send you to a special clinic for routine checkups. Generally, these visits will be brief but will help to determine if your neurostimulator is working properly and providing relief of your symptoms. Be sure to inform your doctor if you change your address. If you must change doctors, your present doctor may recommend a new doctor. Confirm that your new doctor has your medical history. Contact your doctor if any of the following events occur: • You have pain, redness, or swelling at the incision site more than 6 weeks after the surgery. • You have new or unusual abdominal pain, cramping, nausea, or vomiting at any time after surgery. • You are experiencing an increase in your nausea or vomiting. The neurostimulator may simply require an adjustment to a different therapy setting, or there could be a problem with the lead or neurostimulator. Your doctor should be able to determine the cause of the problem and correct it. Doctor visits and when to call your doctor Enterra Ascent ® | Patient Therapy Guide | 2026-06 3 Label symbols The following symbols appear within this manual or on the back cover. Label symbols Manufacturer MR Conditional Rx Only or prescription only Date of manufacture Use-by-date Catalogue or reference number Sterilized using ethylene oxide Do not resterilize Do not use if package is damaged and consult instructions for use Double sterile barrier system with protective packaging inside Do not reuse/single use only Consult instructions for use or consult electronic instructions for use Medical device Country of origin Enterra Ascent ® | Patient Therapy Guide | 2026-06 4 Table of contents Doctor visits and when to call your doctor .................2 Label symbols ........................................................................3 Glossary....................................................................................6 About this manual ................................................................8 Indications (purpose of the neurostimulation system) ...................9 Contraindications (medical procedures that are not allowed) ................10 Warnings ................................................................................11 Precautions ...........................................................................16 Individualization of treatment ........................................17 Risks .........................................................................................18 Your Enterra Ascent System ............................................21 What to expect from your implant procedure ..........22 How your Enterra Ascent System is implanted ..........22 Implanting the leads ...............................................................23 Implanting the neurostimulator ........................................23 Programming the neurostimulator ..................................23 Living with your Enterra Ascent System ......................24 Healing from surgery .............................................................24 Table of contents Enterra Ascent ® | Patient Therapy Guide | 2026-06 5 Activities following surgery .................................................24 Battery information ............................................................25 Replacement surgery.........................................................25 Your Enterra identification card .....................................26 Some common questions ...............................................27 Neurostimulator disposal .................................................31 Appendix A: Information on electromagnetic interference ...........................................................................31 Home, public, and occupational environment ..........31 Enterra System is generally safe if precautions are taken ......................................................................................32 Theft detectors and security screening devices .........33 Medical and hospital environment ..................................36 Safe from electromagnetic interference .......................36 Precautions required ..............................................................37 Unsafe or special precautions ............................................38 Appendix B: Enterra Ascent Neurostimulator model 10102 communications regulations ...............42 Appendix C: MRI Guidelines ............................................43 Enterra Medical Neurostimulation System limited warranty 1 (U.S. customers only) .....................................54 Index ........................................................................................58 Table of contents Enterra Ascent ® | Patient Therapy Guide | 2026-06 6 Glossary Contraindications - A medical term meaning that a procedure, device, or drug, etc. should always be avoided because the risk is greater than any possible benefit. Diathermy - Therapy in which high-frequency currents (shortwave, microwave, ultrasound) produce heat in body tissues to treat certain conditions. Electrocautery - A procedure using electrical current to stop bleeding of blood vessels. It is used during most surgeries. Electrolysis - A procedure using electrical current to remove hair. EMI (Electromagnetic Interference) - Electrical or magnetic energy that is strong enough to interfere with o…

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Date (16/09/2026) Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request FCC ID: 2BH4M-10102 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, Enterra Medical, Inc. hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation Internal Device Photos (see note below) Note: Identification of any measures taken by the submitting party to prevent unauthorized disclosure: The information for which confidential treatment is sought is not accessible to the user (i.e., the circuit board is enclosed in a hermetically sealed can). Additionally, the information is kept confidential by Enterra Medical, Inc. and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Name: Adam Willson Title: Design Quality Engineer

Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 1 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 1 of 8 Electronic Document Control Contents 1 REVISION HISTORY ..................................................................................................................................... 1 2 PURPOSE .................................................................................................................................................. 1 3 PHYSICAL REPRESENTATION REFERENCE ........................................................................................................ 1 4 ENTERRA ASCENT ® , MODEL: 10102, FRONT VIEW ......................................................................................... 2 5 ENTERRA ASCENT ® , MODEL: 10102, REAR VIEW ........................................................................................... 4 6 ENTERRA ASCENT ® , MODEL: 10102, RIGHT SIDE VIEW ................................................................................... 5 7 ENTERRA ASCENT ® , MODEL: 10102, TOP VIEW ............................................................................................. 6 8 ENTERRA ASCENT ® , MODEL: 10102, LEFT SIDE VIEW ..................................................................................... 7 9 ENTERRA ASCENT ® , MODEL: 10102, BOTTOM VIEW ...................................................................................... 8 1 REVISION HISTORY See electronic system for dates and approvals Enterra Medical confidential This document is property and confidential to Enterra Medical. Do not reproduce it, reveal it to unauthorized persons or distribute outside Enterra Medical without authorization. Revision Revision Description Approval A Initial Release Author: Aaron Grant Development: Andrew Zoller Quality Engineer: Adam Willson Regulatory: Therese Radtke 2 PURPOSE This document provides external photographs of the Enterra Ascent® Implantable Pulse Generator (IPG), Model: 10102. 3 PHYSICAL REPRESENTATION REFERENCE The reference device shown in the photographs is as follows: Brand Name: Enterra Ascent® Model: 10102 Serial Number: EMT001018E Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 2 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 2 of 8 Electronic Document Control 4 ENTERRA ASCENT ® , MODEL: 10102, FRONT VIEW Figure 1: Enterra Ascent®, Model: 10102 Front View (with dimensions for reference) 62mm 50mm Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 3 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 3 of 8 Electronic Document Control Figure 2: Enterra Ascent®, Model: 10102, Front View (without dimensions) Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 4 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 4 of 8 Electronic Document Control 5 ENTERRA ASCENT ® , MODEL: 10102, REAR VIEW Figure 3: Enterra Ascent®, Model: 10102, Rear View Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 5 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 5 of 8 Electronic Document Control 6 ENTERRA ASCENT ® , MODEL: 10102, RIGHT SIDE VIEW Figure 4: Enterra Ascent®, Model: 10102, Right Side View (with dimensions for reference) Figure 5: Enterra Ascent®, Model: 10102, Right Side View (without dimensions) 12.65mm Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 6 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 6 of 8 Electronic Document Control 7 ENTERRA ASCENT ® , MODEL: 10102, TOP VIEW Figure 6: Enterra Ascent®, Model: 10102, Top View Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 7 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 7 of 8 Electronic Document Control 8 ENTERRA ASCENT ® , MODEL: 10102, LEFT SIDE VIEW Figure 7: Enterra Ascent®, Model: 10102, Left Side View Enterra Medical Document No. DHF007-PD-04783 Revision: A Page 8 of 8 Title: Enterra Ascent ® IPG Model: 10102 External Pictures Page 8 of 8 Electronic Document Control 9 ENTERRA ASCENT ® , MODEL: 10102, BOTTOM VIEW Figure 8: Enterra Ascent®, Model: 10102, Bottom View

TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 September 09, 2026 TUV SUD America CB 401 Edgewater Place, Suite 500 Wakefield, MA 01880 Attention: Director of Certification RE: Analysis of RF Exposure for Portable and Mobile use per CFR Title 47 Chapter I Subchapter A §1.1307(b)(3)(i)(A) and RSS-102 Issue 6 December 15, 2023 FCC ID: 2BH4M-10102 General Information: Applicant: Enterra Medical, Inc. Environment: General Population/Uncontrolled Exposure Exposure Conditions: Portable Technical Information: Minimum Test Separation Distance: 5 mm Highest Operating Frequency: 2480 MHz Antenna Type: IPG Header Antenna Antenna Gain: -15.5 dBi Maximum Conducted Output Power: -2.2 dBm, 0.60 mW The EUT is exempt from routine RF exposure evaluation under the 1 mW blanket exemption specified in §1.1307(b)(3)(i)(A), as its maximum conducted output power is 0.60 mW. This determination is based on the guidance provided in Sections 2.1.1 and 2.1.2 of FCC KDB 447498 D04. The EUT also complies with the RSS-102 exemption limits for routine SAR evaluation, as defined in Section 6.3 and Table 11. For implanted medical device applications, the most conservative exemption threshold of 1 mW has been applied. Since the maximum conducted output power is below this threshold, the device qualifies for exemption from routine SAR evaluation. Sincerely, Ferdie S. Custodio Name Authorized Signatory Title: Senior EMC Test Engineer /Wireless Team Lead

10040 Mesa Rim Road San Diego CA, 92121 USA TÜV SÜD America, Inc. Phone: (858) 678-1400 www.TÜV-sud-america.com TÜV SÜD Roxtra 328983 DIVPS Main V4 SIGNATURE NAME JOB TITLE RESPONSIBLE FOR ISSUE DATE Omar Castillo Senior EMC / Wireless Test Engineer Authorized Signatory September 16, 2026 Signatures in this approval box have checked this document in line with the requirements of TÜV SÜD document control rules. EXECUTIVE SUMMARY A sample of this product was tested and found to be compliant with FCC 47 CFR Part 15C, ISED RSS-247 and ISED RSS-GEN 2023, Issue 4 (2025-07) and Issue 5 (2018-04) + A2 (2021-02) for the tests detailed in section 1.3. Radio Test Report Manufacturer: Enterra Medical, Inc. IPG. Model: 10102 IPG In accordance with FCC 47 CFR Part 15C and ISED RSS-247 and ISED RSS-GEN Prepared for: Enterra Medical, Inc. Wayzata Blvd, Suite 400 5353 St. Louis Park, MN 55416 COMMERCIAL-IN-CONFIDENCE Document 0721002703-01 Issue 03 DISCLAIMER AND COPYRIGHT This report has been prepared by TÜV SÜD America with all reasonable skill and care. The document is confidential to the potential Client and TÜV SÜD America. No part of this document may be reproduced without the prior written approval of TÜV SÜD America. ACCREDITATION Our A2LA Accreditation does not cover opinions and interpretations and any expressed are outside the scope of our A2LA Accreditation. Test Report - Document 0721002703-01 Issue 03 COMMERCIAL-IN-CONFIDENCE Page 1 of 51 Contents 1 Report Summary .................................................................................................................... 2 1.1 Report Modification Record ...................................................................................................... 2 1.2 Introduction .............................................................................................................................. 2 1.3 Brief Summary of Results ......................................................................................................... 3 1.4 Product Information .................................................................................................................. 4 1.5 Deviations from the Standard ................................................................................................... 4 1.6 EUT Modification Record.......................................................................................................... 4 1.7 Test Location ........................................................................................................................... 4 2 Test Details ............................................................................................................................. 5 2.1 Antenna Requirement .............................................................................................................. 5 2.2 Restricted Band Edges ............................................................................................................. 6 2.3 AC Power Line Conducted Emissions ...................................................................................... 9 2.4 Emission Bandwidth ............................................................................................................... 10 2.5 Maximum Conducted Output Power ....................................................................................... 18 2.6 Authorised Band Edges .......................................................................................................... 21 2.7 Spurious Radiated Emissions ................................................................................................. 23 2.8 Power Spectral Density .......................................................................................................... 46 3 Photographs ......................................................................................................................... 49 3.1 Equipment Under Test (EUT) ................................................................................................. 49 4 Test Equipment Information ................................................................................................ 50 4.1 General Test Equipment Used ............................................................................................... 50 4.2 Customer Support Equipment ................................................................................................ 50 5 Measurement Uncertainty .................................................................................................... 51 Test Report - Document 0721002703-01 Issue 03 COMMERCIAL-IN-CONFIDENCE Page 2 of 51 1 Report Summary 1.1 Report Modification Record Alterations and additions to this report will be issued to the holders of each copy in the form of a complete document. Issue Description of Change Date of Issue 01 First version August 07, 2025 02 Added FCC ID under Section 1.2 September 15, 2026 03 Added RBW/VBW/Detector as applicable under Section 2.4,2.7 and 2.8 September 16, 2026 Added Peak measurements under Section 2.5 Table 1 1.2 Introduction Applicant Enterra Medical, Inc. Manufacturer Enterra Medical, Inc. Model Number(s) 10102 IPG Serial Number(s) EMT 000295E and EMT 000293E Hardware Version(s) N/A Software Version(s) 1.1.0/87 FCC ID 2BH4M-10102 Number of Samples Tested 2 Test Specification/Issue/Date FCC 47 CFR Part 15C, ISED RSS-247 and ISED RSS- GEN 2023, Issue 4 (2025-07), Issue 5 (2018-04) + A2 (2021-02) Test Plan/Issue/Date DHF010-DVP-03534 Enterra Ascent IPG FCC 15.247 and EN 300 328 RF test protocol rev B Order Number Date 0721002703 04-August-2025 Date of Receipt of EUT 02-July-2025 Start of Test 02-July-2025 Finish of Test 10-July-2025 Name of Engineer(s) Miguel Angel Rabago Garcia and Ferdinand Custodio Related Document(s) ANSI C63.10 (2020) KDB 662911 D01 v02r01 KDB 996369 D04 Module Integration Guide v02 ANSI C63.4 (2014) Test Report - Document 0721002703-01 Issue 03 COMMERCIAL-IN-CONFID…

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Rancho Bernardo Facility 16936 Via Del Campo San Diego, CA 92127 TÜV SÜD America, Inc. Phone: (858) 678-1400 www.TÜV-sud-america.com 10040 Mesa Rim Road San Diego CA 92121 US TÜV SÜD SIGNATURE NAME JOB TITLE RESPONSIBLE FOR ISSUE DATE Ferdinand Custodio Senior EMC Test Engineer/Wireless Team Lead Authorised Signatory Sept 09 2026 Signatures in this approval box have checked this document in line with the requirements of TÜV SÜD document control rules. Antenna Test Report Manufacturer: Enterra Medical, Inc. Model: 10102 In accordance with FCC antenna information requirements the application for certification Prepared for: Enterra Medical, Inc. 5353 Wayzata Blvd. Suite 400 St Louis Park, MN 55416 FCC Exhibit Report Document 0721022405 Issue 02 DISCLAIMER AND COPYRIGHT This report has been prepared by TÜV SÜD America with all reasonable skill and care. The document is confidential to the potential Client and TÜV SÜD America. No part of this document may be reproduced without the prior written approval of TÜV SÜD America. Test Report - Document 0721022405 Issue 02 FCC Exhibit Report Page 1 of 32 Contents 1 Report Summary ..................................................................................................................... 2 1.1 Report Modification Record ....................................................................................................... 2 1.2 Introduction ............................................................................................................................... 2 1.3 Product Information ................................................................................................................... 3 1.4 Test Location ............................................................................................................................ 3 2 Test Details .............................................................................................................................. 4 2.1 2D Antenna Pattern................................................................................................................... 4 3 Photographs ...........................................................................................................................30 3.1 Equipment Under Test (EUT) ...................................................................................................30 4 Test Equipment Information ..................................................................................................31 4.1 General Test Equipment Used .................................................................................................31 4.2 Customer Support Equipment ..................................................................................................31 5 Measurement Uncertainty .....................................................................................................32 Test Report - Document 0721022405 Issue 02 FCC Exhibit Report Page 2 of 32 1 Report Summary 1.1 Report Modification Record Alterations and additions to this report will be issued to the holders of each copy in the form of a complete document. Issue Description of Change Date of Issue 01 First version 09-04-2026 02 Update to Antenna Gain in section 1.2 09-09-2026 Table 1 1.2 Introduction Applicant Enterra Medical, Inc. Manufacturer Enterra Medical, Inc. Model Number 10102 Antenna Type IPG Header Antenna Antenna Gain -15.5 dBi Host Information Model 10102 IPG / SN EMT000295E Order Number Date 0721022405 03-Sept-2026 Date of Receipt of EUT 03-Sept-2026 Start of Test 03-Sept-2026 Finish of Test 03-Sept-2026 Name of Engineer(s) Joe Salvador Test Report - Document 0721022405 Issue 01 COMMERCIAL-IN-CONFIDENCE Page 3 of 32 1.3 Product Information 1.3.1 Technical Description The antenna being verified is an IPG header antenna installed in Model 10102 IPG manufactured by Enterra Medical, Inc. The EUT has test lead connected to a USB adaptor utilized to configure the BLE transmit channel. 1.3.2 Test Configuration The host IPG was set to transmit 0dBm CW on Low (2402 MHz), Mid (2440 MHz) and High (2480 MHz) channels. 1.4 Test Location TÜV SÜD conducted the following tests at our San Diego Test Laboratory. Test Name Name of Engineer(s) Accreditation Configuration and Mode: Model 10102 IPG / TX Mode CW 0dBm 2D Antenna Pattern Ferdinand Custodio N/A Table 2 Laboratory Address: 10040 Mesa Rim Road, San Diego, CA, 92121, USA Test Report - Document 0721022405 Issue 01 COMMERCIAL-IN-CONFIDENCE Page 4 of 32 2 Test Details 2.1 2D Antenna Pattern 2.1.1 Host Equipment Under Test and Modification State Host Model 10102 IPG SN EMT000295E @ 0dBm setting 2.1.2 Date of Test 03-Sept-2026 2.1.3 EUT orientations used for verifications Figure 1 Device Vertical Header Up Antenna Header Test Report - Document 0721022405 Issue 01 COMMERCIAL-IN-CONFIDENCE Page 5 of …

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