Garmin ECG App
2 catalogue numbers from 1.x, listed by Garmin International, Inc., United States, under Electrocardiograph Software For Over-The-Counter Use. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
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 | Garmin International, 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 |
| Record published | 2023-01-24 |
| Record revised | 2025-11-20 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.x | In distribution | |
| 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 |
| 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 |
|---|---|
| K221774 | 2023-01-12 |
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.