FDA records identify the ECG App as a device submission from Apple, Inc. Check the exact record and intended use rather than extending one ECG entry to every health feature on a watch.
An FDA record applies to the device and use named in that record. It does not establish the status of every feature on a consumer smartwatch.
FDA record details
| Record field | FDA entry |
|---|---|
| Device name | ECG App |
| Applicant | Apple, Inc. |
| 510(k) number | K201525 |
| Product code | QDA |
| Decision | Substantially equivalent |
| Decision date | October 8, 2020 |
The FDA’s K201525 record provides those submission details. FDA’s De Novo record for the ECG App lists a separate regulatory action. Read the record’s indications and labeling when evaluating a specific model or feature.
Check the feature and version
- Record the feature name, application version, watch model, and manufacturer.
- Find the FDA record by device name, applicant, or submission number.
- Compare the entry with the feature and version named in the product labeling.
- Read the record’s device classification, decision, and intended use.
- Check for separate records for other features on the same watch.
- Do not assume a wellness feature shares the regulatory status of an ECG app.
For a separate device category, see FDA classification records for pulse oximeters. To read an FDA record for a fall-injury-prevention wearable, see what the FDA record says about the Tango Belt. Browse heart and blood pressure devices.
This page describes device records and regulatory status. Speak with a doctor about health concerns or questions about using a medical device.
Sources
- ECG App 510(k) record K201525, FDA
- ECG App De Novo record DEN180044, FDA
- FDA product code classification database
Use the FDA device status lookup checklist for other product records.
Common questions
Does an FDA record for an ECG app cover every smartwatch health feature?
No. A record identifies a particular device and use. Check separate records for separate features.
What information does the ECG App 510(k) record show?
It lists the device name, applicant, product code, decision, and other submission details.
Does the app's record identify every supported watch model?
Check the device description and labeling in the linked FDA record for model-specific details.