510(k) Report

Devices descending from K161717

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221772NeuroRPMNew Touch Digital, Inc.20230—
+1K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+2K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—