Electrocardiograph Software For Over-The-Counter Use
FDA product code QDA · Class II (moderate risk) · 21 CFR 870.2345 · Cardiovascular
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.
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240795 | Withings ECG AppQDA · Traditional | Withings | 06/15/2025SE |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0)QDA · Traditional | Whoop., Inc. | 04/04/2025SE |
| K240909 | Samsung ECG App v 1.3 (ECG)QDA · Traditional | Samsung Electronics Co., Ltd. | 08/02/2024SE |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA · Traditional | Samsung Electronics Co., Ltd. | 05/02/2023SE |
| K221774 | Garmin ECG AppQDA · Traditional | Garmin International, Inc. | 01/12/2023SE |
| K201525 | ECG AppQDA · Traditional | Apple, Inc. | 10/08/2020SE |
| K200948 | Fitbit ECG AppQDA · Traditional | Fitbit, Inc. | 09/11/2020SE |
| K201168 | ECG Monitor AppQDA · Traditional | Samsung Electronics Co., Ltd. | 08/04/2020SE |