Whoop ECG Feature
WHOOP ECG Feature is an over-the-counter mobile application used with the WHOOP Strap by adults aged 22 or older. It records a single-channel electrocardiogram similar to Lead I and…
WHOOP ECG Feature is an over-the-counter mobile application used with the WHOOP Strap by adults aged 22 or older. It records a single-channel electrocardiogram similar to Lead I and analyzes a 30-second spot-check recording to classify the rhythm.
For a classifiable recording, outputs include normal sinus rhythm, atrial fibrillation, low heart rate at or below 50 beats per minute, and high heart rate at or above 100. Results are informational; users should consult a qualified healthcare professional before interpreting them or taking clinical action. It is not recommended for users with other known arrhythmias.
Recording Reports
After completing onboarding, users can view their recordings and download ECG reports as PDF files. The feature can also return an inconclusive result or identify an unsuccessful reading.
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 | Whoop, Inc., 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) | K243236 |
| Record published | 2025-06-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.x | 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 |
| Fitbit ECG App | Fitbit LLC | 1 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 1 |
| Google ECG App | Fitbit LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243236 | 2025-04-04 |
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.