Fitbit ECG App
The Fitbit ECG App records and analyzes a single-channel electrocardiogram using electrical sensors on a compatible Fitbit wrist-worn device. Its device app analyzes a 30-second recording…
The Fitbit ECG App records and analyzes a single-channel electrocardiogram using electrical sensors on a compatible Fitbit wrist-worn device. Its device app analyzes a 30-second recording and can classify a suitable waveform as atrial fibrillation or normal sinus rhythm, or return an inconclusive result.
The connected mobile app stores result history and displays a PDF waveform qualitatively similar to Lead I. The wrist device measures electrical potential differences for acquisition, while the mobile interface supports review of recordings and results.
Listed Item
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
User and Result Scope
The app is intended for over-the-counter use by people aged 22 or older. Its ECG information supplements rhythm classification and is informational; the output supports review with a qualified healthcare professional. The AFib detection function is not recommended for users with other known arrhythmias.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Fitbit LLC, United States |
|---|---|
| FDA product code | QDA |
| Device type | Electrocardiograph Software For Over-The-Counter Use |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2345 |
| Establishment | Manufacturer |
| 510(k) | K200948 |
| Record published | 2020-10-07 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FB603 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| ECG Monitor App | Samsung Electronics Co., Ltd. | 3 |
| ECG 2.0 App | Apple Inc. | 2 |
| ECG App | Apple Inc. | 2 |
| Garmin ECG App | Garmin International, Inc. | 2 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 1 |
| Google ECG App | Fitbit LLC | 1 |
| Whoop ECG Feature | Whoop, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200948 | 2020-09-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.