Cardiac electrophysiology application software

Intended purpose

The Garmin ECG app is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to create, record, store, transfer, and display a single-channel electrocardiograph similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm (SR) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is not intended for use by people under 22 years old. The ECG app is intended for over-the-counter (OTC) use. 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 SR, and it is not intended to replace traditional methods of diagnosis or treatment.