FDA 510(k) Applications for Medical Device Product Code: PFW ()

FDA 510(k) Applications for Medical Device Product Code "PFW"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K072256	HILL LABORATORIES CO.	HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL	03/12/2008
K081075	NANO VIBRONIX LTD.	PAINSHIELD MD	08/22/2008
K221210	NanoVibronix, Inc.	PainShield MD PLUS	11/23/2022
K130978	ZetrOZ INC	ZTX ULTRASONIC DIATHERMY DEVICE	11/06/2013
K191568	ZetrOZ Systems, LLC	sam 2.0 Long Duration Ultrasound System	03/06/2020
K223019	ZetrOZ Systems, LLC	sam 2.0 Long Ultrasound Device	06/23/2023
K211513	ZetrOZ Systems, LLC	sam X1 Long Duration Ultrasound Device	08/18/2021