Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007710601

FEI Number

3007710601

Entity Name

WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

No. 35 Baiqiao Rd., Ehu Town, Xishan District,, Wuxi Jiangsu 214116, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Wuxi Jiajian Medical Instrument Co., Ltd (Owner Number: 10029771)

Owner / Operator Contact Address

No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, CN-JS 214116, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122812

PMA Number

N/A

All Registered Proprietary Names

Transcutaneous Electrical Nerve Stimulator (model TENS WMPS6-1) Infrared Heating Device, PM-750 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) Jiajian® Acupuncture Needle Ultra Fine Dry Needles Sterile Acupuncture Needles Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) Jiajian® CMN Stimulator Transcutaneous Electrical Nerve Stimulator THETA-Stim, Model TS-1000 Needle Stimulator, Model CMNS6-1 and CMNS6-2 NEEDLE STIMULATOR, Model BD-360 Jiajian® Self-adhesive Electrode Welllife CM13088 Welllife CM4040 Welllife CM5050 Self-Adhering Electrodes WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP Jiajian® TENS Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 & WQ-6F

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	2023-02-20
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2016-09-05
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2025-12-17
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2009-09-03
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-04-15
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2013-08-21
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-09-22
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2021-09-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2009-06-24
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2026-02-09
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2012-05-09
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2013-04-11

Official Correspondent

Wenqing Wang

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (920) 6019045

Related Public Records

Same Entity

Wuxi Jiajian Medical Instrument Co., Ltd

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007710601. Last updated year: 2026. Please use registration number 3007710601 when referencing this establishment in official correspondence.