510(k) Report

Devices descending from K213519

4 later devices reach Rune Labs Tremor Transducer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+1K220820Parky AppH2o Bilisim Yazilim20223—
+2K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+2K250153Neu PlatformNeuhealth Digital, Ltd.20251—