Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004438577

FEI Number

3004438577

Entity Name

SHENZHEN XFT MEDICAL LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 203, Building 1 and Building 4B, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen Guangdong 518118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen XFT Medical Limited (Owner Number: 10028364)

Owner / Operator Contact Address

Room 203, Building 1, and Building 4B, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New, Shenzhen, CN-GD 518118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162718

PMA Number

N/A

All Registered Proprietary Names

SaeboStim Pro, Nerve And Muscle Stimulator, model XFT-2000 XFT, Nerve And Muscle Stimulator, model XFT-2000 XFT XFT, Nerve And Muscle Stimulator, Model XFT-2001E, XFT-2001EA XFT, Suction Rescue Device, Model: XFT-2015A, XFT-2015B Pelvic muscle trainer XFT-0010CK XFT, Nerve And Muscle Stimulator, Model XFT-2003K XFT, Foot Drop System, Model XFT-2001D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2020-04-28
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-04-28
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2009-01-22
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2020-10-30
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2024-12-30
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-12-17
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-11-23
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2021-11-23
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2017-12-25

Official Correspondent

Mars Chen

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Shenzhen XFT Medical Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004438577. Last updated year: 2026. Please use registration number 3004438577 when referencing this establishment in official correspondence.