510(k) Report

Devices descending from K971318

10 later devices reach MM-1 Movement Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+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—
+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—
+4K250153Neu PlatformNeuhealth Digital, Ltd.20251—