ECG App
Apple’s ECG app is software that works with the electrical heart sensor in compatible Apple Watch models to record an electrocardiogram. The recording represents electrical pulses from the…
Apple’s ECG app is software that works with the electrical heart sensor in compatible Apple Watch models to record an electrocardiogram. The recording represents electrical pulses from the heart, and the app checks the signal for an irregular rhythm pattern associated with atrial fibrillation.
The app displays a classification for an individual recording. Apple states that the result applies only to that recording and that the app is not intended for people under 22. The software is a recording and screening feature, not a diagnosis.
Hardware Relationship
The watch sensor detects electrical signals through contact with the wrist and the other hand touching the Digital Crown. The app processes and presents the recorded waveform and its classification.
The app requires a supported watch and regional availability.
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 | Apple 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 | Specification developer, Manufacturer |
| 510(k) | DEN180044 |
| Record published | 2019-01-14 |
| Record revised | 2025-11-20 (version 4) |
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 |
|---|---|---|
| Feature Version 1.x | In distribution | |
| Feature Version 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 |
| 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 |
|---|---|
| K201525 | 2020-10-08 |
| DEN180044 | 2018-09-11 |
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.