# K240795: Withings ECG App

- Pathway: 510(k) (Traditional)
- Applicant: Withings
- Decided: Jun 15, 2025 after 450 days
- Product code: QDA (Electrocardiograph Software For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180044 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201525: ECG App, Apple, Inc. (2020) Summary page 5.

## Indications for use
The Withings ECG App is a software-only device intended for use with the ScanWatch to create, record, store, transfer and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The Withings ECG App determines the presence of atrial fibrillation (AFib), sinus rhythm and high heart rate (no signs of AFib with heart rate 100-150 bpm) on a classifiable waveform. The Withings ECG App is not recommended for users with other known arrhythmias. The Withings ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Withings ECG App is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Withings ECG App is intended to supplement rhythm classification for the purposes of discriminating AFib from normal rhythms. The device is not intended to replace traditional methods or diagnosis. The ECG acquired by ScanWatch is not intended for manual and/or automated measurement of QT-interval. The Withings ECG app is not intended for use by people under 22 years old.

Source page: https://510kreport.com/device/K240795
Methodology: https://510kreport.com/methodology