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Fuji Dynamics Limited: FDA-registered device maker in Dongguan Guangdong, China, 11 510(k) clearances

Name: Fuji Dynamics Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fuji Dynamics Limited is registered with the FDA (registration 9615033) in Dongguan Guangdong, China. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated January 22, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9615033
FEI number: 3005479189
Address: Room 201, 40 Gao Yu South Road, Pin Shan, Tangxia Town, Dongguan Guangdong, China, 523710
Owner or operator: FUJI DYNAMICS LIMITED (9015622)
Roles: Manufacturer
First device listed: August 7, 2000
Registered through: 2026
Brand names listed: EASY TENS PLUS, EMPI PHOENIX, FD EMS, FD TENS 2010, FD TENS 2030, FD TENS 2090 & FD TENS 2095, FUJI TENS III, IF 4K and more

Devices it lists

Device	Product code	Class	Role	Source
Instrument, Dowel Cutting	GZQ	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 22, 2016	K152676	FD TENS 2090, FD TENS 2095	GZJ	Substantially Equivalent	Fuji Dynamics , Ltd.	accessdata.fda.gov
January 13, 2016	K152374	LL TENS 160A, LL TENS 160B	NUH	Substantially Equivalent	Fuji Dynamics , Ltd.	accessdata.fda.gov
May 6, 2013	K124016	EMPI PHOENIX	IPF	Substantially Equivalent	Djo, LLC	accessdata.fda.gov
January 7, 2010	K092780	INF 4160 PLUS, MODEL D-FJ31F	LIH	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
December 13, 2007	K063642	FD EMS, MODEL # D-FJ30E	IPF	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
January 25, 2006	K052813	FD TENS 2030, MODEL DFJ24T	GZJ	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
February 11, 2005	K043407	INF 4160, MODEL D-FJ27F	LIH	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
May 20, 2004	K041164	L-TENS	GZJ	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
July 6, 2000	K994266	FDTENS 2010	GZJ	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
July 6, 2000	K994265	MEDISANA DIGITAL TENS	GZJ	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
December 22, 1989	K893874	FUJITENS III	GZQ	Substantially Equivalent	Altoona Medical Supply	accessdata.fda.gov

Compare with other makers

Updated January 22, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.