Withings ECG App

The Withings ECG App is a software-only mobile application for over-the-counter use that works with the Withings ScanWatch smartwatch to create, record, store, and display a single-channel electrocardiogram similar to Lead I. It classifies heart rhythms to detect atrial fibrillation, sinus rhythm, and high heart rate (100-150 bpm), providing informational results intended to supplement but not replace clinical diagnosis.

Both the subject device and predicate (Apple ECG 2.0 App) are software-only devices with AFib detection algorithms that acquire sensor data from a smartwatch, process it through algorithms, and display rhythm classification to users. The main difference is electrode placement: Withings uses back-of-watch and bezel electrodes (requiring two-finger contact), while Apple uses back-of-watch and digital crown electrodes (requiring single-finger contact). Both operate on identical 30-second recording sessions and use single-channel Lead I equivalent ECG measurements.

IEC 60601-2-47:2012 (ambulatory ECG systems), IEC 62368-1:2014 (thermal and electrical safety), ANSI/AAMI ES60601-1:2005 (medical electrical equipment basic safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment), IEC 62304:2006/Amd 1:2015 (medical device software), AAMI/ANSI/IEC 62366-1:2015 (usability engineering), ISO 14971 (risk management), FCC Part 15 (radiofrequency), and AAMI TIR69:2017 and ANSI IEEE C63.27-2017 (wireless coexistence).

Both devices share identical intended use (OTC electrocardiograph software for AFib and rhythm detection), same regulatory classification (Class II, Product Code QDA), same principle of operation (smartwatch sensor data acquisition followed by algorithm processing and rhythm classification), and same mechanism of action (electrical potential measurement between watch electrodes to generate ECG waveform). The minor difference in electrode location and finger contact method was validated through human factors testing and clinical studies demonstrating equivalent performance: 99.7% sensitivity for AFib and 99.8% specificity for sinus rhythm in the subject device versus equivalent predicate performance.