2AFBP-MCT22PZio MCT ECG Patch Monitor

CONFIDENTIAL - DRAFT Zio® MCT IMPORTANT INFORMATION 2 CONFIDENTIAL - DRAFT ABOUT THE ZIO MCT Zio MCT data analysis Your Zio MCT data is analyzed at the iRhythm Clinical Centers. iRhythm is an Independent Diagnostic Testing Facility (IDTF) dedicated to providing world-class diagnostic service. As an IDTF, we adhere to Medicare Independent Diagnostic Testing Facility Performance Standards. A link to these standards (42 C.F.R. Section 410.33) can be found at the iRhythm website www.irhythmtech.com. Patient identification Before placing your device in the prepaid envelope, please write your name on the line above the return address. By writing your name on the envelope you are providing another method of identification for the Patch and Gateway and are consenting to the potential viewing of your name on the envelope. You may choose to not write your name on the envelope. Notice of privacy practices As participants in your health care, we are required by applicable federal and state law to maintain the privacy of your Protected Health Information (PHI). Our full Notice of Privacy Practices, found at www.irhythmtech. com, describes our privacy practices, our legal duties, and your rights concerning your PHI. Indications for use The Zio MCT ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on 3 CONFIDENTIAL - DRAFT beat-to-beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light- headedness, pre-syncope, syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients. Contraindications • Do not use Zio MCT for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real- time or in- patient monitoring should be prescribed. • Do not use the Zio MCT for patients with known history of life-threatening arrhythmias. • Do not use the Zio MCT in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI. • Do not use the Zio MCT on patients with neuro- stimulator, as it may disrupt the quality of ECG data. • Do not use the Zio MCT on patients who do not have the competency to wear the device for the prescribed monitoring period. Warnings • Do not use the Zio MCT Patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patient may experience skin irritation. • Do not reuse the Zio MCT Patch on multiple patients. It is a single patient use device. Reuse will cause incorrect patient data and patient may experience skin irritation. • Do not use the Zio MCT on patients residing in areas with limited to no cellular reception. 4 CONFIDENTIAL - DRAFT • Do not modify the Zio MCT system. 5 CONFIDENTIAL - DRAFT Warnings (cont’d) • The Zio MCT system is MR Unsafe! -Do not expose the Zio MCT patch or gateway to a magnetic resonance (MR) environment. -The Zio MCT patch or gateway may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core. -Thermal injury and burns may occur due to the metal components of the Zio MCT patch that can heat during MR scanning. -The Zio MCT patch may generate artifacts in the MR image. -The Zio MCT patch or gateway may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner. If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio MCT Patch from the patient’s chest. Call iRhythm Customer Care at 1.888.693.2401 CAUTION: Federal (USA) law restricts the sale of this device to or on the order of a physician. Precautions • Safety and effectiveness of the Zio MCT Patch on patients receiving any form of pacing therapy has not been established. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified. • Safety and effectiveness of the Zio MCT system on pediatric patients (younger than 18 years old) has not been established. • The Zio MCT system includes temperature and humidity limitations when stored/transported. If exposed during storage/transport, patients may experience degradation of adhesive performance causing the Zio MCT patch to slip or fall off during the patient wear duration. 6 CONFIDENTIAL - DRAFT • The Zio MCT system has a shelf-life date. Use of expired device may cause a degradation of ECG signal quality and/or low battery condition. • Do not use the Zio MCT system if package is damaged. Device may not perform as intended. • Keep device and packaging away from young children. Contents may be harmful if swallowed. Patch contains button cell batteries that are not accessible during normal use but, if exposed, are known choking hazards and may cause severe tissue injury if ingested. • Registration errors may result in limited functionality or erroneous ECG reporting. Utmost caution should be applied to ensure that patient registration is accurate and complete. The patient is an intended operator Package Contents 1 Zio MCT patch 1 Zio MCT gateway, containing: 1 postage-paid return envelope 1 Skin Prep & Placement Kit containing: 1 patch card template 1 disposable razor 1 abrader disc 4 alcohol wipes 1 Application instructions 1 Wearing your Zio manual & button press log containing: 1 adhesive remover wipe 7 CONFIDENTIAL - DRAFT Symbols Gl…

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March 16, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: section 2.911(d)(7) filing To whom it may concern, This letter is to confirm that Brice Bobzien has accepted responsibility to act as the agent for service of process as acknowledged by the applicant, iRhythm Technologies, Inc. Brice Bobzien confirms he is not associated with or part of any TCB or test lab. U.S. Agent: Brice Bobzien Title: Chief Financial Officer Company Name: iRhythm Technologies, Inc. Address: 699 8 th Street, Suite 600, San Francisco, CA 94103 Telephone No: 415-632-5700 Email: [email protected] FRN (FCC Registration Number): 0024652950 The applicant accepts and acknowledges the obligation to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Signature of Applicant: iRhythm Technologies, Inc. (must be signed by the contact of record in the FCC database for the applicant grantee code): Signature of U.S. Agent (if different from applicant): N/A Name: Brice Bobzien Name: N/A Date: March 16, 2023 Date: N/A DocuSign Envelope ID: B773A352-C3EF-4F15-900B-00688309474C

March 16, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Attestation regarding ‘covered’ equipment and the Covered List FCC ID: 2AFBP-MCT22P To whom it may concern, Per 2.911(d)(5)(i), iRhythm Technologies, Inc. certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Per 2.911(d)(5)(ii), iRhythm Technologies, Inc. certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing “covered” equipment. Sincerely, Brice Bobzien Chief Financial Officer DocuSign Envelope ID: 15265A8F-DC94-4D0C-AF7E-737A89DD1851

41039 Boyce Road 510-578-3500 Phone Fremont, CA. 94538 Page 1 of 1 October 13, 2022 Federal Communications Commission Office of Engineering and Technology Laboratory Division 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AFBP-MCT22P To whom it may concern: The enclosed documents constitute a formal submittal and application for FCC Equipment Authorization (original certification) for a medical patch with Bluetooth Low Energy (BLE) transceiver pursuant to the following rules: Subpart C of Part 15 of FCC Rules (CFR 47), §15.247 NTS Labs, LLC, as duly authorized agent prepared this submittal. A copy of the letter of our appointment as agent is included with the application. If there are any questions or if further information is needed, please contact National Technical Systems for assistance. Sincerely, David W. Bare Chief Engineer DWB/dmg

Request for Confidentiality September 21, 2022 Subject: Confidentiality Request for: 2AFBP-MCT22P Pursuant to FCC 47 CRF 0.457(d) and 0.459 and/or RSP-100, the applicant requests that a part of the subject FCC and/or ISED application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Permanent Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Schematics Short Term Test Setup Photos Short Term Permanent* User’s Manual iRhythm Technologies, Inc. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify FCC in the event information regarding the product or the product is made available to the public. FCC will then release the documents listed above for public disclosure pursuant to FCC KDB 726920 D01. The applicant understands that until such time that Innovation Science and Economic Development Canada distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to ISED. Sincerely, By: (Signature/Title) (Printed name) DocuSign Envelope ID: D837F816-7322-4C3C-A665-280AE8A7AC58 Brice Bobzien CFO

February 13, 2023 To whom it may concern, We, the undersigned, hereby authorize David W. Bare of NTS Labs, LLC to act on our behalf, as our agent, in the following matters related to the FCC and/or Industry Canada approval of our products: report submittal, related correspondence, the signing of all documents relating to these matters, and any other lawful activity necessary to obtain such certification. Any act carried out by NTS Labs, LLC within the scope of this authorization shall have the same affect as our own. This authorization shall expire 12 months from original date. Sincerely, Brice Bobzien Chief Financial Officer DocuSign Envelope ID: 820006C0-BB8A-426D-9F7B-E6774E86B630

PN# LB 10097 rev. 02 Zio Monitor Bottom Housing Laser Mark Page 1 of 2 IRHYTHM TECHNOLOGIES, INC. CONFIDENTIAL SPECIFICATIONS: NOTE CATEGORY SPECIFICATION 1 PRINT METHOD Permanent indelible high-resolution mark on the substrate surface via Keyence MD- U1020C UV Laser Marker (ETS0167) 2 PRINT COLOR Black (REFERENCE ONLY) 3 ARTWORK LB10097_02.MX4 - Refer to Reference Images (Provided by iRhythm) 4 FONT Print using ‘Söhne Kräftig’ font in Medium (See attached ‘Sohne-Kraftig.otf’ ) 5 INSPECTION N/A. THIS SPEC DEFINES THE LASER MARK INTENT AND DESIGN, NOT THE PHYSICAL LASER MARK. INSPECTION FOR LASER MARKING TO BE PERFORMED AT THE UPPER LEVEL PHYSICAL COMPONENT OR SUBASSEMBLY THAT USES LB10097. PN# LB 10097 rev. 02 Zio Monitor Bottom Housing Laser Mark Page 2 of 2 IRHYTHM TECHNOLOGIES, INC. CONFIDENTIAL REFERENCE IMAGES Standard (Zio monitor, Zio MCT) Configuration – example SN is MMM8888MMM : Demonstration Unit Configuration (Human Readable SN and 2D code will read “DEMODEVICE”):

41039 Boyce Road Fremont, CA. 94538 510-578-3500 Phone Test Report FR-163245.01-OTA Rev 1 " Over the Air Pseudo Active Antenna Measurements iRhythm Technologies Inc. Model: Zio MCT ECG Monitor PN: DSB0002 APPLICANT: iRhythm Technologies Inc. 699 8 th St #600 San Francisco, CA 64103 US TEST SITE(S): NTS Labs LLC 41039 Boyce Road. Fremont, CA. 94538-2435 PROJECT NUMBER: PR134700 REPORT DATE: September 21, 2022 REISSUE DATE: April 12, 2023 FINAL TEST DATE(S): September 21, 2022 TOTAL NUMBER OF PAGES: 22 This report and the information contained herein represent the results of testing of only those articles / products identified in this document and selected by the client. The tests were performed to specifications and/or procedures selected by the client. NTS Labs LLC makes no representations expressed or implied that such testing fully demonstrates efficiency, performance, reliability, or any other characteristic of the articles being tested, or similar products. This report should not be relied upon as an endorsement or certification by NTS Labs LLC of the equipment tested, nor does it present any statement whatsoever as to its merchantability or fitness of the test article or similar products, for a particular purpose. This report shall not be reproduced except in full without written approval from NTS Labs LLC. NTS Labs LLC Project number PR163245 Report Date September 21, 2022 Reissue Date April 12, 2023 Test Report FR-163245.01-OTA Rev 1 Page 2 of 22 VALIDATING SIGNATORIES TECHNICAL REVIEWER: ______________________________ Deniz Demirci Senior Wireless / EMC Engineer FINAL REPORT PREPARER: ______________________________ Deniz Demirci Senior Wireless / EMC Engineer QUALITY ASSURANCE DELEGATE ______________________________ David Guidotti Senior Technical Writer NTS Labs LLC Project number PR163245 Report Date September 21, 2022 Reissue Date April 12, 2023 Test Report FR-163245.01-OTA Rev 1 Page 3 of 22 REVISION HISTORY Rev # Date Comments Modified By 0 September 21, 2022 Draft Release - 1 April 12, 2023 Antenna gain information calculated. TRP, Directivity and Efficiency results removed. Deniz Demirci NTS Labs LLC Project number PR163245 Report Date September 21, 2022 Reissue Date April 12, 2023 Test Report FR-163245.01-OTA Rev 1 Page 4 of 22 TABLE OF CONTENTS OVER THE AIR PSEUDO ACTIVE ANTENNA MEASUREMENTS ........................................................................................................ 1 VALIDATING SIGNATORIES .................................................................................................................................................. 2 REVISION HISTORY ................................................................................................................................................................. 3 TABLE OF CONTENTS ............................................................................................................................................................. 4 PHYSICAL LAYOUT AND SITE DESCRIPTION ................................................................................................................. 5 WIRELESS TEST FACILITY ...................................................................................................................................................... 5 ANECHOIC CHAMBER .............................................................................................................................................................. 5 MULTI AXES POSITIONING SYSTEM (MAPS) ........................................................................................................................ 5 QUIET ZONE .............................................................................................................................................................................. 6 EMQUEST SOFTWARE ............................................................................................................................................................. 6 TEST METHODS ......................................................................................................................................................................... 6 TOTAL RADIATED POWER ...................................................................................................................................................... 6 EQUIPMENT UNDER TEST (EUT) INFORMATION ........................................................................................................... 7 MODIFICATIONS .................................................................................................................................................................... 7 MEASUREMENTS ...................................................................................................................................................................... 7 TESTED BY ............................................................................................................................................................................ 13 TEST EQUIPMENT LIST ........................................................................................................................................................ 15 APPENDIX A: CHAMBER REFERENCE SETUP ............................................................................................................... 16 APPENDIX B: EUT PHOTOS .................................................................................................................................................. 17 APPENDIX C: TEST SETUP PHOTOS .................................................................................................................................. 19 END OF REPORT ...................................................................................................................................................................... 22 NTS Labs LLC Project number PR163245 Report Date September 21, 2022 Reissue…

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EMC Test Data Client: Contact: Standard: Specific Details Device complies with SAR exclusion as the output power is less than 1mW Summary of Results Test Engineer: David Bare SAR Exclusion Objective: Evaluate the RF Exposure requirements per FCC 1.1310, 2.1093. Date of Test: 3/3/2023 Jason Van VlietProject Engineer: David Bare FCC Part 15.247, RSS-247Class: N/A iRhythmPR Number: PR163245 Model: Zio MCT ECG Monitor T-Log Number: TL163245-RANA-Patch Project Manager: Deepa Shetty TL163245-RANA-Patch conducted.xlsMPE Calc 03-Mar-23Page 1 of 1

41039 Boyce Road Fremont, CA. 94538 510-578-3500 Phone File: FR-163245.04-NARF Rev 1 Page 1 EMC Test Report Application for FCC Grant of Equipment Authorization FCC Part 15 Subpart C Innovation, Science and Economic Development Canada RSS-Gen Issue 5 / RSS-247 Issue 2 Model: Zio MCT ECG Monitor FCC ID: 2AFBP-MCT22P APPLICANT: iRhythm Technologies Inc. 699 8th Street #600 San Francisco, CA 94103 TEST SITE(S): NTS Labs LLC 41039 Boyce Road. Fremont, CA. 94538-2435 IC SITE REGISTRATION #: 2845B-7 PROJECT NUMBER: PR163245 REPORT DATE: September 29, 2022 RE-ISSUED DATE: February 2, 2023 FINAL TEST DATES: September 22 and 23, 2022 TOTAL NUMBER OF PAGES: 54 This report and the information contained herein represent the results of testing of only those articles / products identified in this document and selected by the client. The tests were performed to specifications and/or procedures selected by the client. NTS Labs LLC makes no representations expressed or implied that such testing fully demonstrates efficiency, performance, reliability, or any other characteristic of the articles being tested, or similar products. This report should not be relied upon as an endorsement or certification by NTS Labs LLC of the equipment tested, nor does it present any statement whatsoever as to its merchantability or fitness of the test article or similar products, for a particular purpose. This report shall not be reproduced except in full without written approval from NTS Labs LLC. NTS Labs LLC Project number PR163245 Report Date: September 29, 2022, Re-issued: February 2, 2023 Test Report FR-163245.04-NARF Rev 1 Page 2 VALIDATING SIGNATORIES PROGRAM MGR _________________________ David W. Bare Chief Engineer TECHNICAL REVIEWER: _________________________ David W. Bare Chief Engineer FINAL REPORT PREPARER: _________________________ David Guidotti Senior Technical Writer QUALITY ASSURANCE DELEGATE _________________________ Gary Izard Senior Technical Writer NTS Labs LLC Project number PR163245 Report Date: September 29, 2022, Re-issued: February 2, 2023 Test Report FR-163245.04-NARF Rev 1 Page 3 REVISION HISTORY Rev# Date Comments Modified By - September 29, 2022 First release 1 February 2, 2023 The test description on Page 15 was revised to add a note about testing in the additional 2 orthogonal axis. The statement about factors on page 21 was revised. The missing antenna and amplifier on page 23 were added. dwb NTS Labs LLC Project number PR163245 Report Date: September 29, 2022, Re-issued: February 2, 2023 Test Report FR-163245.04-NARF Rev 1 Page 4 TABLE OF CONTENTS COVER PAGE ............................................................................................................................................................. 1 VALIDATING SIGNATORIES ................................................................................................................................. 2 REVISION HISTORY ................................................................................................................................................ 3 TABLE OF CONTENTS ............................................................................................................................................ 4 SCOPE .......................................................................................................................................................................... 5 OBJECTIVE ................................................................................................................................................................ 6 STATEMENT OF COMPLIANCE ........................................................................................................................... 7 DEVIATIONS FROM THE STANDARDS .............................................................................................................. 7 TEST RESULTS SUMMARY .................................................................................................................................... 8 DIGITAL TRANSMISSION SYSTEMS (2400 – 2483.5MHZ) .............................................................................. 8 MEASUREMENT UNCERTAINTIES .................................................................................................................... 8 EQUIPMENT UNDER TEST (EUT) DETAILS ...................................................................................................... 9 GENERAL ................................................................................................................................................................ 9 OTHER EUT DETAILS ........................................................................................................................................... 9 ANTENNA SYSTEM .............................................................................................................................................. 9 ENCLOSURE ........................................................................................................................................................... 9 MODIFICATIONS ................................................................................................................................................... 9 SUPPORT EQUIPMENT ......................................................................................................................................... 9 EUT INTERFACE PORTS .................................................................................................................................... 10 EUT OPERATION ................................................................................................................................................. 10 TEST SITE ................................................................................................................................................................. 11 GENERAL INFORMATION ..............................................…

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41039 Boyce Road510-578-3500 Phone Fremont, CA. 94538510-440-9525 Fax Project number PR163245 Page 1 DTS Antenna 41039 Boyce Road510-578-3500 Phone Fremont, CA. 94538510-440-9525 Fax Project number PR163245 Page 2 Radiated Emissions – Below 30 MHz 41039 Boyce Road510-578-3500 Phone Fremont, CA. 94538510-440-9525 Fax Project number PR163245 Page 3 Radiated Emissions – Below 1 GHz 41039 Boyce Road510-578-3500 Phone Fremont, CA. 94538510-440-9525 Fax Project number PR163245 Page 4 2.4GHz Spurious 41039 Boyce Road510-578-3500 Phone Fremont, CA. 94538510-440-9525 Fax Project number PR163245 Page 5 41039 Boyce Road510-578-3500 Phone Fremont, CA. 94538510-440-9525 Fax Project number PR163245 Page 6