WHOOP ECG (electrocardiogram) Feature (1.0)
FDA 510(k) clearance K243236 · decided 2025-04-04
Clearance details
- K-number
- K243236
- Device name
- WHOOP ECG (electrocardiogram) Feature (1.0)
- Applicant
- Whoop., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-10
- Decision date
- 2025-04-04
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- QDA
- Device class
- 2
- Regulation number
- 870.2345
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Whoop.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Withings ECG App (K240795) | Withings | 2025-06-15 |
| Samsung ECG App v 1.3 (ECG) (K240909) | Samsung Electronics Co., Ltd. | 2024-08-02 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292) | Samsung Electronics Co., Ltd. | 2023-05-02 |
| Garmin ECG App (K221774) | Garmin International, Inc. | 2023-01-12 |
| ECG App (K201525) | Apple, Inc. | 2020-10-08 |
| Fitbit ECG App (K200948) | Fitbit, Inc. | 2020-09-11 |
| ECG Monitor App (K201168) | Samsung Electronics Co., Ltd. | 2020-08-04 |
| ECG App (DEN180044) | Apple, Inc. | 2018-09-11 |
Recalls involving this device
No recalls on record reference this clearance.