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).…

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.

TGA Public Summary