510(k) Report

Devices descending from K181352

10 later devices reach Loop System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232445CSF-4 (CSF-4)Cardiacsense20240—
+1K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+1K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+1K220351Polso WatchChronisense Medical, Ltd.20220—
+2K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.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—
+2K232915EpiMonitorEmpatica S.r.l.20241—
+3K250515EpiMonitorEmpatica S.r.l.20250—