510(k) Report

Devices descending from K210133

8 later devices reach Current Health Monitoring System Gen 2 (G2) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+1K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+1K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+2K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+2K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+2K252981EmbraceMiniEmpatica S.r.l.20251—
+2K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+2K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—