510(k) Report

Devices descending from K181077

10 later devices reach ActiGraph CentrePoint Insight Watch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC20231—
+1K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+2K243513DCM (PW-DCM)Pneumowave, Ltd.20250—
+2K232915EpiMonitorEmpatica S.r.l.20241—
+2K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+3K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+3K252981EmbraceMiniEmpatica S.r.l.20251—
+3K250515EpiMonitorEmpatica S.r.l.20250—
+3K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+3K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—