510(k) Report

Devices descending from K080545

23 later devices reach Actitrainer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233987Veraband™Arbor Medical Innovations, LLC20240—
+1K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+1K181077ActiGraph CentrePoint Insight WatchActigraph201810—
+1K143512ActiSpec Activity MonitorSleep Modus, Inc.20150—
+1K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+2K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC20231—
+2K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+2K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+2K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+3K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+3K243513DCM (PW-DCM)Pneumowave, Ltd.20250—
+3K232915EpiMonitorEmpatica S.r.l.20241—
+3K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+3K221772NeuroRPMNew Touch Digital, Inc.20230—
+3K220820Parky AppH2o Bilisim Yazilim20223—
+3K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+4K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+4K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+4K252981EmbraceMiniEmpatica S.r.l.20251—
+4K250515EpiMonitorEmpatica S.r.l.20250—
+4K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+4K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+4K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—