510(k) Report

Devices descending from K182543

19 later devices reach Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+2K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+2K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+3K241397HinscopeHinlab Sas20240—
+3K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+3K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+3K222550Current Health SystemCurrent Health, Ltd.20221—
+3K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+4K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+4K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+4K232915EpiMonitorEmpatica S.r.l.20241—
+4K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+4K231506Current Health SystemCurrent Health, Ltd.20230—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+5K252981EmbraceMiniEmpatica S.r.l.20251—
+5K250515EpiMonitorEmpatica S.r.l.20250—
+5K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+5K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—