Cardiac electrophysiology application software

Intended purpose

The ECG app is a software-only mobile medical application that is intended to be used with the Apple Watch to create, record, store, transfer and display a single-channel electrocardiagram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AF) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the 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 with a qualified health professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AF from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use in people under 22 years old.