510(k) Report

Devices descending from K040554

27 later devices reach Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143512ActiSpec Activity MonitorSleep Modus, Inc.20150—
+1K111514SBV2, Multicharger Model MC10V2Sleep Performance D.B.A. Fatigue Science20112—
+1K080545ActitrainerActigraph, LLC200823—
+2K233987Veraband™Arbor Medical Innovations, LLC20240—
+2K233618Oxevision Sleep DeviceOxehealth Limited20240—
+2K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+2K181077ActiGraph CentrePoint Insight WatchActigraph201810—
+2K151784ActTrustCondor Instruments Ltda. - Epp20160—
+2K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+3K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC20231—
+3K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+3K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+3K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+4K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+4K243513DCM (PW-DCM)Pneumowave, Ltd.20250—
+4K232915EpiMonitorEmpatica S.r.l.20241—
+4K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+4K221772NeuroRPMNew Touch Digital, Inc.20230—
+4K220820Parky AppH2o Bilisim Yazilim20223—
+4K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+5K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K252981EmbraceMiniEmpatica S.r.l.20251—
+5K250515EpiMonitorEmpatica S.r.l.20250—
+5K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+5K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+5K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—