Garmin ECG App
FDA 510(k) K221774 · Garmin International, Inc.
510(k) numberK221774
Submission
- Device name
- Garmin ECG App
- Applicant
- Garmin International, Inc.
Olathe, KS, US - Received
- June 21, 2022
- Decision date
- January 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDA – Electrocardiograph Software For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2345
- Specialty
- 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.
Other 510(k)s with product code QDA
| 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 |
| 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 |
Questions and answers
When was Garmin ECG App cleared by the FDA?
Garmin ECG App (K221774) received a 510(k) decision of Substantially Equivalent on January 12, 2023, 205 days after the submission was received.
What is the product code of K221774?
The FDA product code is QDA – Electrocardiograph Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2345.