510(k) Report

Devices descending from K010270

11 later devices reach Tremorometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063872KinesiaCleveland Medical Devices, Inc.200710—
+2K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+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—
+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—
+5K250153Neu PlatformNeuhealth Digital, Ltd.20251—