Device Dossier
Self-care monitoring web-based application software
Device Dossier for Self-care monitoring web-based application software (Self-care monitoring web-based application software, Class IIa, sponsor Emergo).…
- GMDN category: Self-care monitoring web-based application software
Intended purpose
The WHOOP Irregular Heart Rhythm Notifications software is intended to opportunistically display a notification of possible AFib when sufficient data is available for analysis. The software is not recommended for users with known atrial fibrillation and is intended for home use by lay people aged 22 years and over.