GYD — Transducer, Tremor Class II

FDA Device Classification

Classification Details

Product Code
GYD
Device Class
Class II
Regulation Number
882.1950
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250153neuhealth digitalNeu PlatformApril 25, 2025
K221772new touch digitalNeuroRPMMarch 17, 2023
K220820h2o bilisim yazilimParky AppNovember 17, 2022
K213519rune labsRune Labs Tremor Transducer SystemJune 10, 2022
K211887gkc manufacturing ptyPersonal Kinetigraph (PKG) System Gen 2 PlusMarch 11, 2022
K161717gkc manufacturing ptyPersonal Kinetigraph (PKG) SystemSeptember 20, 2016
K140086gkc manufacturing ptyPERSONAL KINETIGRAPH (PKG) SYSTEMAugust 22, 2014
K063872cleveland medical devicesKINESIAApril 6, 2007
K010270flexable systemsTREMOROMETERJuly 25, 2001
K011429telecom medicalMODEL 100 ACTIVITY MONITORJuly 13, 2001
K971318axon instrumentsMM-1 MOVEMENT MONITORJuly 28, 1997
K782036columbus instruments intlTREMOR MONITORJanuary 23, 1979