Electrocardiograph Software For Over-the-counter Use
Cardiovascular · 21 CFR 870.2345
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
Recent MDR events
34 adverse event reports on file
- APPLE WATCHApr 30, 2026InjuryApple Inc.MW5187513
- KARDIA MOBILEApr 16, 2026MalfunctionAlivecorMW5186921
- WHOOP BANDFeb 24, 2026InjuryWhoop Inc.MW5184337
- GOOGLE PIXEL WATCH 4Dec 22, 2025MalfunctionUnknownMW5180944
- FITBITDec 22, 2025MalfunctionFitbit LlcMW5180945
- APPLE WATCH ULTRA 2Dec 10, 2025MalfunctionApple Inc.MW5180218
- WHOOP 4.0Oct 20, 2025InjuryWhoop, Inc.MW5177669
- HBANDMar 31, 2025DeathUnkMW5168385
- APPLE WATCHDec 27, 2024MalfunctionApple Inc.MW5164056
- FITVIINov 29, 2024MalfunctionFitviiiMW5163039
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
28 firms currently registered for this product code
Alivecor
Mountain View, CA, US
Icon Llc
Rochester, NY, US
Samsung Electronics Co., Ltd. Mobile Experience Business
Suwon-si Gyeonggi, KR
Rr Donnelley-supply Chain Solutions
Plover, WI, US
Tecan Cdmo Solutions Pn Sdn. Bhd.
Penang Pulau Pinang, MY
Ryder Electronics (shenzhen) Ltd.
Shenzhen Guangdong, CN
Hypertec Hcm Llc
Plainfield, IN, US
Garmin International, Inc.
Olathe, KS, US
Omron Healthcare Co., Ltd. Matsusaka Factory
Matsusaka Mie, JP
Apple Inc.
Cupertino, CA, US
Omron Healthcare Co., Ltd.
MUKO Kyoto, JP
Omron Healthcare, Inc.
Hoffman Est, IL, US
Fitbit Llc
San Francisco, CA, US
Quipment Inc.
Kennesaw, GA, US
Whoop, Inc.
Boston, MA, US
Anza Packaging & Displays De Mexico S. De R.l. De C.v.
TIJUANA Baja California, MX
510(k) clearances
9 clearances for this product code
- WithingsJun 15, 2025
K240795 · Withings ECG App
- Whoop., Inc.Apr 4, 2025
K243236 · WHOOP ECG (electrocardiogram) Feature (1.0)
- Samsung Electronics Co., Ltd.Aug 2, 2024
K240909 · Samsung ECG App v 1.3 (ECG)
- Samsung Electronics Co., Ltd.May 2, 2023
K230292 · Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
- Garmin International, Inc.Jan 12, 2023
K221774 · Garmin ECG App
- Apple, Inc.Oct 8, 2020
K201525 · ECG App
- Fitbit, Inc.Sep 11, 2020
K200948 · Fitbit ECG App
- Samsung Electronics Co., Ltd.Aug 4, 2020
K201168 · ECG Monitor App