Device Dossier
Multichannel electrocardiograph, interpretive, home-use
Device Dossier for Multichannel electrocardiograph, interpretive, home-use (Multichannel electrocardiograph, interpretive, home-use, Class IIa, sponsor…
- GMDN category: Multichannel electrocardiograph, interpretive, home-use
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.