510(k) Report

Devices descending from K140086

9 later devices reach Personal Kinetigraph (PKG) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+1K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+2K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+2K221772NeuroRPMNew Touch Digital, Inc.20230—
+2K220820Parky AppH2o Bilisim Yazilim20223—
+2K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+3K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+3K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+3K250153Neu PlatformNeuhealth Digital, Ltd.20251—