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Shenzhen XFT Medical Limited: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances

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

Shenzhen XFT Medical Limited is registered with the FDA (registration 3004438577) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 8, 2021. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3004438577
Address: Block B, Building 4, Shenzhen Biomedicine Innovations Industrial Park #14 Jinhui Road, Jinsha Community, Kengzi Subdistrict, Pingshan District, Shenzhen Guangdong, China, 518118
Owner or operator: Shenzhen XFT Medical Limited (10028364)
Roles: Manufacturer
First device listed: January 22, 2009
Registered through: 2027
Brand names listed: Pelvic muscle trainer XFT-0010CK, SaeboStim Pro, Nerve And Muscle Stimulator, model XFT-2000, XFT, XFT, Foot Drop System, Model XFT-2001D, XFT, Nerve And Muscle Stimulator, Model XFT-2001E, XFT-2001EA, XFT, Nerve And Muscle Stimulator, Model XFT-2003K, XFT, Nerve And Muscle Stimulator, model XFT-2000, XFT, Rehabilitation Robot, XFT-2005A and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Device, Biofeedback	HCC	2	Manufacturer	accessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-Sterile	NNX	1	Manufacturer	accessdata.fda.gov
Exerciser, Finger, Powered	JFA	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	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, Neuromuscular, External Functional	GZI	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
July 8, 2021	K211094	Nerve and Muscle Stimulator	IPF	Substantially Equivalent	Shenzhen Xft Medical Limited	accessdata.fda.gov
September 23, 2020	K193276	Nerve and Muscle Stimulator	GZI	Substantially Equivalent	Shenzhen Xft Medical Limited	accessdata.fda.gov
April 11, 2020	K193275	Nerve and Muscle Stimulator	IPF	Substantially Equivalent	Shenzhen Xft Medical Limited	accessdata.fda.gov
November 30, 2017	K162718	Foot Drop System (Model XFT-2001D)	GZI	Substantially Equivalent	Shenzhen Xft Medical Limited	accessdata.fda.gov

Compare with other makers

Updated July 8, 2021. 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.