FDA 510(k) Applications for Medical Device Product Code: GYD (Transducer, Tremor)

FDA 510(k) Applications for Medical Device Product Code "GYD"
(Transducer, Tremor)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K971318	AXON INSTRUMENTS, INC.	MM-1 MOVEMENT MONITOR	07/28/1997
K063872	CLEVELAND MEDICAL DEVICES, INC.	KINESIA	04/06/2007
K010270	FLEXABLE SYSTEMS, INC.	TREMOROMETER	07/25/2001
K211887	GKC Manufacturing Pty Ltd	Personal Kinetigraph (PKG) System Gen 2 Plus	03/11/2022
K140086	GKC MANUFACTURING PTY LTD.	PERSONAL KINETIGRAPH (PKG) SYSTEM	08/22/2014
K161717	GKC MANUFACTURING PTY LTD.	Personal Kinetigraph (PKG) System	09/20/2016
K220820	H2O Bilisim Yazilim	Parky App	11/17/2022
K250153	Neuhealth Digital Ltd.	Neu Platform	04/25/2025
K221772	New Touch Digital Inc.	NeuroRPM	03/17/2023
K213519	Rune Labs, Inc.	Rune Labs Tremor Transducer System	06/10/2022
K011429	TELECOM MEDICAL, INC.	MODEL 100 ACTIVITY MONITOR	07/13/2001