2AOH8-NINerivioInfinity Transceiver

LBL-INF-0220-1.0 Version 1.0 December 2022 NerivioInfinity™ A wireless non-invasive rechargeable neuromodulation device for treatment of migraine USER MANUAL 2Page | © 2022 Theranica Bio-Electronics LTD. (“Theranica”), all rights reserved. The manual or any of its parts should not be reproduced without the written permission of Theranica. Theranica reserves the right to change or improve its products and accompanying technical literature without specific notice. Manufacturer: Theranica Bio-Electronics LTD. 4 Ha-Omanut St., Netanya 4250438, Israel Tel: +972-72-3909-763, Fax: +972-72-3909762 Web: www.theranica.com 2AOH8-NI 3Page | Table of content 1. Introduction 5 1.1. About this manual 5 1.2. Product overview 5 1.3. Product functions 6 1.4. Package content 6 2. Glossary 7 3. Labels and symbols 8 4. Safety 10 4.1. Conditions for use 10 4.2. Warnings, precautions and Adverse Events 10 5. What does the treatment feel like? 14 6. Using the device 14 6.1. Starting for the first time 14 6.2. Treating a migraine Headache 23 6.3. Storing the device for next use 30 6.4. Reviewing your migraine diary 31 6.5. Performing over-the-air (ota) software update 31 6.6. Performing software recovery 32 7. Cleaning, maintenance and disposal 32 7.1. Cleaning and maintenance 32 7.2. Disposal 33 8. Troubleshooting 33 8.1. General 33 8.2. Main errors and messages 37 8.3. LED status 37 8.4. Customer support 38 9. Operation specification 38 9.1. Environment operating conditions 38 9.2. Environmental storage and transportation conditions between uses 38 9.3. Environmental trasnportation and storage conditions 39 9.4. Electrical properties 39 10. Technical specifications 39 11. Smartphone requirements 42 12. Cybersecurity 42 13. Potential Adverse Reactions 43 14. Classification 43 15. EMC statement 43 15.1. Electromagnetic Documentation compliance 45 15.2. Electromagnetic emissions 45 15.3. Electromagnetic immunity 46 4Page | 15.4. Performance criteria per IEC 60601-1-2, IEC 60601-2-10 46 15.5. Recommended separation distances 47 16. FCC radio frequency interference statement 47 17. Applicable standards 48 5Page | 1. INTRODUCTION 1.1. ABOUT THIS MANUAL This manual provides the information necessary for the user to effectively use the NerivioInfinity device. • Do not attempt to perform any procedure before carefully reading all instructions. • Always follow product labeling and the manufacturer recommendations. • For any inquiry, please contact customer support at [email protected]. 1.2. PRODUCT OVERVIEW NerivioInfinity is a durable, wearable, battery-powered medical device for the acute or preventive treatment of migraine with or without aura in patients 12 years of age or older. NerivioInfinity is controlled by a mobile application. The NerivioInfinity is intended for self- administration at a home environment. The device is worn on the upper arm and transmits transcutaneous electrical nerve stimulation by applying weak electrical pulses that invoke conditioned pain modulation (CPM) to inhibit migraine pain. NerivioInfinity is intended for self-administration at the onset of a migraine episode for acute treatment or every other day for prevention. The NerivioInfinity system includes several main components: 1. The NerivioInfinity device. The device shall be connected to electrodes (see #2) and together are placed on the arm. 2. Electrodes kit (soft-layer). The electrodes are connected to the device to comprise a single functioning unit. 3. Armband and extension. The armband should be wrapped around the device on the arm to improve the contact between the device and the skin, to secure its location on the arm and to conceal the device to enable a discreet treatment. 4. Software mobile application (app) 5. Carrying bag 6. USB charging cable, type A to type C. The external side of the NerivioInfinity device includes a power button and two-color LED indicator that signals various modes of operation. The internal side includes magnetic connectors to the electrodes that deliver neurostimulation signals. The armband secures the device in its location. The device is controlled by an application which is installed on a smartphone. The application controls the device, retrieves operational records from the device and stores the data for further retrospective processing/reviewing. The application enables the user to activate the stimulation, control the stimulation intensity, monitor the treatment duration and pause or stop the stimulation. The application also provides notifications and indications on the connection status and on the remaining 6Page | battery charge level. It also offers a migraine dairy feature which enables to track information about your migraine attacks. 1.3. PRODUCT FUNCTIONS • The device is battery-powered; the battery is internal, integrated, and rechargeable. • The device includes a replaceable electrodes kit accessory, providing electrical stimulation to the skin. • The device is activated by a power button. • Armband which should be wrapped around the device on the arm to improve the contact between the device and the skin, to secure its location on the arm and to conceal the device to enable a discreet treatment. An extension is also provided for larger arm sizes. • An application (app) installed on a smartphone to control and monitor the treatment (as well as provide other features). 1.4. PACKAGE CONTENT • 1 NerivioInfinity ® device • 2 sets of electrodes kit (soft-layer) each in a foil wrapper • 1 Armband • 1 Armband extension • 1 Carrying bag • 1 QuickStart guide • 1 USB type-A to USB type-C charging cable • 1 Leaflet 7Page | 2. GLOSSARY App: Mobile application running on a smartphone LED: Light-Emitting Diode EMC: Electromagnetic compatibility TENS: Transcutaneous electrical nerve stimulation FDA: The Food and Drug Administration FCC: The Federal Communications Commission 8Page | 3. LABELS AND SYMBOLS Symbol Description www.nerivio.com Read and fully understand user manual before using this …

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Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com Section 2.911(d)(5)(i) Certification – Equipment Type Company name: Theranica Bio-Electronics LTD. Address: 4 Ha-Omanut St., 4250438, Netanya, Israel Product Name: NerivioInfinity FCC ID: 2AOH8-NI Model(s): FGD000100 2.911(d)(5)(i) Equipment Type We, Theranica Bio-Electronics (“the applicant”) certify that the equipment for which authorization is sought through certification is not: • Prohibited from receiving an equipment authorization pursuant to § 2.903; of the FCC rules. • Identified as an equipment type in the “Covered List” NOTE 1 Yours sincerely, Name: Ofer Rivkind Date: 2-May-2023 Title and Company name: Director of HW and system, Theranica Bio-Electronics, LTD. NOTE 1 “Covered List”; is the List of Equipment and Services Covered By Section 2 of The Secure Networks Act, available at https://www.fcc.gov/supplychain/coveredlist References; 1) 986446 D01 Covered Equipment v01 https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=325672 2) Federal Register document 2022-28263 published on 02/06/23 https://www.federalregister.gov/documents/2023/02/06/2022-28263/protecting-against-national-security- threats-to-the-communications-supply-chain-through-the 2.911 (d)(5)(i) Equipment Type Attestation v1.2 Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com Section 2.911(d)(5)(ii) Certification – Applicant (Covered List) Company name: Theranica Bio-Electronics LTD. Address: 4 Ha-Omanut St., 4250438, Netanya, Israel Product Name: NerivioInfinity FCC ID: 2AOH8-NI Model(s): FGD000100 2.911(d)(5)(ii) Applicant filing We, Theranica Bio-Electronics, (“the applicant”) certify that, as of the date of the filing of the application, the applicant is is not identified NOTE 1 on the “Covered List” NOTE 2 , established pursuant to § 1.50002 of this chapter, as an entity producing covered communications equipment. Yours sincerely, Name: Ofer Rivkind Date: 2-May-2023 Title and Company name: Director of HW and system, Theranica Bio-Electronics, LTD. NOTE 1 Delete option not applicable to this application. NOTE 2 “Covered List”; is the List of Equipment and Services Covered By Section 2 of The Secure Networks Act, available at https://www.fcc.gov/supplychain/coveredlist References; 1) 986446 D01 Covered Equipment v01 https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=325672 2) Federal Register document 2022-28263 published on 02/06/23 https://www.federalregister.gov/documents/2023/02/06/2022-28263/protecting-against-national-security- threats-to-the-communications-supply-chain-through-the 2.911 (d)(5)(ii) Applicant Attestation v1.3

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com Section 2.911(d)(5)(ii) Certification – Applicant (Covered List) Company name: Theranica Bio-Electronics LTD. Address: 4 Ha-Omanut St., 4250438, Netanya, Israel Product Name: NerivioInfinity FCC ID: 2AOH8-NI Model(s): FGD000100 2.911(d)(7) USA Designated Agent for Service of Process We, Theranica Bio-Electronics (“the applicant”) designate Theranica USA NOTE1 for the purpose of accepting service of process on behalf of the applicant. Applicant consent: We acknowledge our consent to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and email address of the designated agent and acknowledge our acceptance of our obligation to maintain an agent for service of process in the United States for no less than one year after either we the grantee have permanently terminated all marketing and importation of the applicable equipment within the U.S., or at the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Agent obligation: We acknowledge our obligation to accept service of process in the United States for matters related to the applicable equipment at our physical U.S. address and email address for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or at the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Applicant Company name: Theranica Bio- Electronics LTD Address: 4 Ha-Omanut St. Netanya 4250438 Israel FCC Grantee Code: 2AOH8 Contact Name: Ronen Jashek Telephone No: +972-54-7251024 Email: [email protected] Signature: Title: COO USA Agent Company name: Theranica USA USA Address: 100 Somerset Corporate Boulevard 2nd Floor – Suite 160 Bridgewater, NJ 08807 USA FRN Number: 0027054477 Contact Name: Tim McCarthy Telephone No: 484-999-4447 Email: [email protected] Signature: Title: CEO, Theranica USA Date: 5/2/2023 Date: 2 May 2023 NOTE 1: An applicant located in the United States may designate itself as the agent for service of process. Reference; Federal Register document 2022-28263 published on 02/06/23 Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com https://www.federalregister.gov/documents/2023/02/06/2022-28263/protecting-against-national- security-threats-to-the-communications-supply-chain-through-the

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com Agent Authorization Company: Theranica Bio-Electronics, Ltd. Address: 4 Ha-Omanut st. Netanya 4250438, Israel Product Name: NerivioInfinity Model Number: FGD000100 Product Description: NerivioInfinity (the EUT) is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, and/or every other day for preventive treatment. The EUT is a wearable, battery-powered device. It is powered by a non- detachable, non-replaceable, recharge battery and is operated via a mobile application. The device is worn on a user’s upper arm and delivers transcutaneous electrical nerve stimulation (“TENS”) via weak electrical pulses to achieve migraine pain inhibition via conditional pain modulation (CPM). The NerivioInifinity uses standard BLE 5.0 for communication utilizing off-the-shelf Cypress controller. We authorize MiCOM Labs Inc., 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the certification of above named equipment. We declare that MiCOM Labs Inc. is allowed to forward all information related to the approval and certification of equipment to the regulatory agencies as required and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Signature: Date: 11-May-2023 Name: Ofer Rivkind Title: Directory of HW and System Company: Theranica Bio-Electronics, Ltd.

18-May-23 Tested by: Eng. Vitaly Nazarov Date 18.05.23 Test Antenna Gain Temp 22° Test method Substitution Humidity 46% Project No 7212322306 Atm. pressure 1006 mbar Company Theranica EUT Antenna MIFA on PCB Reference Horn Antenna SII3117 s/n 139055 Freq Gain Generator Rad. Meas GHz dBi dBm dBm 2.4 5.76 -10 -59.89 Double Ridged Waveguide Antenna 1-18 GHz ETS Lindgren 3117 00139055 08/21 08/23 MXG Analog Microwave Signal generator 100 KHz - 40 GHz Agilent N5183A MY50141773 12/22 12/23 EMI RECEIVER-MXE 20Hz-26.5 GHz Keysight N9038A MY52130048 12/22 12/23 18-May-23 Tested by: Eng. Vitaly Nazarov Tested Antenna Antenna MIFA on PCB printed Manufacturer: Cypress Freq Gain Polarization Generator Rad. Meas GHz dBi - dBm dBm 2.4 -1.148 H -10 -66.798 Gain measurements results Antenna radiation pattern -25 -20 -15 -10 -5 0 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180190 200 210 220 230 240 250 260 270 280 290 300 310 320 330 340 350 360 Chart Title 18-May-23 Tested by: Eng. Vitaly Nazarov Freq Gain Polarization Generator Rad. Meas GHz dBi - dBm dBm 2.4 1.5 V -10 -64.131 Gain measurements results Antenna radiation pattern -14 -12 -10 -8 -6 -4 -2 0 2 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180190 200 210 220 230 240 250 260 270 280 290 300 310 320 330 340 350 360 Chart Title

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com Theranica Bio-Electronics, Ltd. 4 Ha-Omanut st. Netanya 4250438, Israel Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: Dec 18, 2022 Subject; Request for Confidentiality FCC ID: 2AOH8-NI To Whom It May Concern, Pursuant to Public Notice DA 04-1705 of the Commission' s policy, in order to comply with the marketing regulations in 47 CFT §2.803 and the importation rules in 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant shot-term confidentiality request on the following attachment(s) for 180 days after the grant as outlined in Public Notice DA 04-1705. • External Photos • Internal Photos • Test Setup Photos • User Manual It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: OFER RIVKIND Name: Ofer Rivkind Title: Director of System and Hardware

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel Tel: +972 (72) 390-9760, Fax: +972 (72) 390-9762, Web: www.theranica.com Theranica Bio-Electronics, Ltd. 4 Ha-Omanut st. Netanya 4250438, Israel Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: Dec 18, 2022 Subject; Request for Confidentiality FCC ID: 2AOH8-NI To Whom It May Concern, Pursuant to the provisions of Sections 0.457 and 0.459 of Commission's rules (47CFR0.457, 0.459), we are requesting the Commission to withhold the following attachment(s) as confidential document from public disclosure indefinitely. • Schematic Diagram • Block Diagram • Part List • Operational Description Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: OFER RIVKIND Name: Ofer Rivkind Title: Director of System and Hardware

External photos

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel www.theranica.com, Web: 9762-390) 72( 972, Fax: +9760-390) 72( 972Tel: + Device label Device label with UDI example

Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel www.theranica.com, Web: 9762-390) 72( 972, Fax: +9760-390) 72( 972Tel: + NerivioInfinity – Internal Photos TOP SIDE Theranica Bio-Electronics, Ltd., 4 Ha-Omanut st., Netanya 4250438, Israel www.theranica.com, Web: 9762-390) 72( 972, Fax: +9760-390) 72( 972Tel: + BOTTOM SIDE

RF Exposure Evaluation Report For Theranica Bioelectronics Ltd. Equipment Under Test: NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI Issued by: The Standards Institution of Israel Industry Division Electrical & Electronics Laboratory EMC Branch 1. Applicant information Applicant: Theranica Bioelectronics Ltd.. Address: 4 Ha-Omanut St., 4250438, P.O.B 16008, Netanya 4206001, Israel Sample for test selected by: The customer The date of tests: November & December 2022 Equipment under test information Description of Equipment Under Test (EUT): NerivioInfinity Transceiver Model: FGD000100 Software version of radio unit: FW Version 4.0.4.70 Hardware version: ELC-PCA-0200-1.0 Manufactured by: Theranica Bio-Electronics Ltd. 2. Test performance Location: SII EMC Section Purpose of test: To prove the safety of radiation harmfulness to the human body for our product Test specifications: FCC KDB 447498 D01 General RF Exposure Guidance v06 This Test Report contains 4 pages and may be used only in full. This Test Report applies only to the specimen tested and may not be applied to other specimens of the same product. 3. Summary of test: Using the general SAR test exclusion guidance in Section 4.2.4 of KDB 447498 D01 v06, we show the device meeting the SAR exemption. Electronics and Telematics Laboratory December 2022 Name: Eng. Yuri Rozenberg Position: Head of EMC Branch. Name: Alexander Konkov. Position: Test engineer. 4. Equipment under test description. *The applicant provided description. 4.1 General description NerivioInfinity Transceiver(the EUT) is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, and/or every other day for preventive treatment. The EUT is a wearable, battery-powered device. It is powered by a non-detachable, non- replaceable, recharge battery and is operated via a mobile application. The device is worn on a user’s upper arm and delivers transcutaneous remote electrical neurostimulation ("REN") via weak electrical pulses to achieve migraine pain inhibition via conditional pain modulation (CPM). The NerivioInifinity uses standard BLE 5.0 for communication utilizing off-the-shelf Cypress controller. EUT technical characteristics Transmitter technical characteristics: Note Assigned frequency band 2400 MHz – 2483.5 MHz - Operating frequency range: 2402 MHz – 2480 MHz - DTS transmitter: BLE 5 - Types of modulation: GFSK - Declare temperature range: 0°C - 35°C Normal indoor use Antenna information Type Manufacturer/Model Antenna gain, dBi BT PCB printed antenna Cypress. MIFA PCB printed -1.6 5. FCC and ISEDC Exemption Limits for Routine Evaluation FCC SAR test exclusions per KDB 447498 KDB 447498 D01 General RF Exposure Guidance v06 Section: 4.3.1. Standalone SAR test exclusion considerations states: 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: [(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, 30 where • f(GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculation • The result is rounded to one decimal place for comparison • The values 3.0 and 7.5 are referred to as numeric thresholds. The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 4.1 f) is applied to determine SAR test exclusion. SAR Test Exclusion Threshold Freq. [GHz] d [mm] Max. power [mW] Calculation result FCC Limit @ 5 mm [mW] SAR Exclusion applicable (Yes/No) 2.402 5 0.58 0.18 3.0 Yes Summary: SAR test exclusion threshold is < 3 for separation distance of 5 mm. Therefore, SAR test is not required.

Test Report No. 7212322306 Applicant : Theranica Bio-Electronics LTD Equipment Under Test: NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI Issued by: The Standards Institution of Israel Industry Division Electrical & Electronics Laboratory EMC Branch Certificate Number: AT-1359 Test Report No.: 7212322306 Page 2 of 32 Pages Title: Test on NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI Applicant: Theranica Bio-Electronics LTD. Address: 4 Ha-Omanut St., 4250438, P.O.B 16008, Netanya 4206001, Israel Sample for test selected by: The customer The date of test: November & December 2022 Description of Equipment under Test (EUT): NerivioInfinity Transceiver Model: FGD000100 Software version: FW Version 4.0.4.70 Hardware version: ELC-PCA-0200-1.0 Manufactured by: Theranica Bio-Electronics LTD. Reference Documents:  CFR 47 FCC (2020) Rules and Regulations: Part 15. Radio frequency devices, Subpart C: Intentional radiators. Section 15.247: Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz, 5725 - 5875 MHz Test Results The EUT was found to be in compliance with the following standard: CFR47 Part 15 Subpart C sections: 15.203, 15.205, 15.207, 15.209 and 15.247. This Test Report contains 32 pages and may be used only in its entirety. This Test Report applies only to the specimen tested and may not be applied to other specimens of the same product. Test Report No.: 7212322306 Page 3 of 32 Pages Title: Test on NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI Table of Contents 1. Summary of Test Results _____________________________________________________ 4 2. EUT Description ____________________________________________________________ 5 2.1. General description: ___________________________________________________________ 5 2.2. Transmitter description: ________________________________________________________ 6 2.3. Test setup: ___________________________________________________________________ 6 2.4. System test configuration: ______________________________________________________ 8 3. Test specification, methods and procedures _______________________________________ 9 4. Testing Facility: ____________________________________________________________ 9 5. Measurement uncertainty _____________________________________________________ 9 6. Transmitter characteristics - test results ________________________________________ 10 6.1. Duty Cycle __________________________________________________________________ 10 6.2. 6dB and Occupied Bandwidth __________________________________________________ 11 6.3. Maximum Peak Conducted Output Power ________________________________________ 13 6.4. Power Spectral Density ________________________________________________________ 15 6.5. Radiated Emissions in Restricted and non-Restricted bands _________________________ 17 6.6. Band-edge measurements ____________________________________________________ 24 6.7. AC power line conducted emission measurement __________________________________ 26 7. Antenna requirements _______________________________________________________ 28 8. Appendix 1: Test equipment used ______________________________________________ 29 9. Appendix 2: Antenna Factor and Cable Loss ____________________________________ 30 10. Appendix 3: Test illustrations _______________________________________________ 31 Test Report No.: 7212322306 Page 4 of 32 Pages Title: Test on NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI 1. Summary of Test Results Transmitter characteristic Ref. Section 6dB and occupied bandwidth 15.247 (a) (2) Maximum peak conducted output power 15.247 (b) (3) Power spectral density 15.247 (e) Radiated emission in restricted and non-restricted bands 15.247 (d), 15.209, 15.205 Band-edge compliance of RF conducted emission 15.247 (d) AC power line conducted emission measurements 15.207 Antenna requirement 15. 203 Electrical & Electronics Laboratory Name: Eng. Yuri Rozenberg 26 March 2023 Tested by: Alexander Konkov Position: Head of Branch Position: Testing Engineer Test Report No.: 7212322306 Page 5 of 32 Pages Title: Test on NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI 2. EUT Description Note: All information in this section was provided by the customer. 2.1. General description: NerivioInfinity Transceiver(the EUT) is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, and/or every other day for preventive treatment. The EUT is a wearable, battery-powered device. It is powered by a non-detachable, non- replaceable, recharge battery and is operated via a mobile application. The device is worn on a user’s upper arm and delivers transcutaneous remote electrical neurostimulation ("REN") via weak electrical pulses to achieve migraine pain inhibition via conditional pain modulation (CPM). The NerivioInifinity uses standard BLE 5.0 for communication utilizing off -the-shelf Cypress controller. The test data contained in this report pertains only to the emissions due to the EUT’s BLE transmitter. Figure 1. Block diagram Figure 2. NerivioInfinity Transceiver Test Report No.: 7212322306 Page 6 of 32 Pages Title: Test on NerivioInfinity Transceiver Model: FGD000100 FCC ID: 2AOH8-NI 2.2. Transmitter description: Type of equipment Combined equipment (Equipment where the radio part is fully integrated within another type of equipment) BLE standards BLE 5 Assigned frequency range from 2400MHz to 2483.5MHz Operating frequency range from 2402MHz to 2480MHz (BLE transceiver) RF channel spacing 1 MHz ( BLE transceiver) Maximum rated output power Effective radiated power (for equipment with no RF connector) -2.3 dBm = 0.58 mW Declare temperature range: 0°C - 35°C Normal indoor use Antenna information Antenna MIFA on PCB printed - without temporary RF connector Manufacturer: …

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Test set up photos. FCC ID: 2AOH8-NI Radiated emissions test set up above 1GHz. Radiated emissions test set up below 30MHz. Radiated emissions test set up above 18GHz. Radiated emissions test set up in 30MHz-1GHz frequency range Conducted emission test set up