Device Dossier

Multichannel electrocardiograph, interpretive, home-use

Device Dossier for Multichannel electrocardiograph, interpretive, home-use (Multichannel electrocardiograph, interpretive, home-use, Class IIa, sponsor…

Intended purpose

The WHOOP ECG feature is intended to determine the presence of atrial fibrillation (AFib), normal sinus rhythm, low heart rate (less than or equal to 50 beats per minute [bpm]), and high heart rate (greater than or equal to 100 bpm) on a classifiable waveform. This is intended for people aged 22 years and over.

TGA Public Summary