ECG Monitor App
Samsung Health Monitor ECG App for Wear OS
1manufacturer
3catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Samsung Electronics Co., Ltd., South Korea |
|---|---|
| FDA product code | QDA |
| Device type | Electrocardiograph Software For Over-The-Counter Use |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K201168 |
| Record published | 2021-08-25 |
| Record revised | 2026-05-07 (version 3) |
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 |
|---|---|---|
| v1.1 | In distribution | |
| v1.1 | In distribution | |
| v1.1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| 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 |
| Whoop ECG Feature | Whoop, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240909 | 2024-08-02 |
| K230292 | 2023-05-02 |
| K201168 | 2020-08-04 |
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.