QuadraTENS

QuadraTENS dual-channel system allows you to relax two sets of muscles simultaneously. It’s ability to target both cranial nerves and large muscle groups is what separates the QuadraTENS…

Registry build 21.09.26

QuadraTENS dual-channel system allows you to relax two sets of muscles simultaneously. It’s ability to target both cranial nerves and large muscle groups is what separates the QuadraTENS from all other TENs systems on the market.

32manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (23), Jiangsu (2), Beijing (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GZJ
Manufacturer City Province Registered as Device types
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Shenzhen Jie Zhong Lian Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
Shenzhen Zifound Infonet Technology Co., Ltd. Shenzhen, Guandong Guangdong Contract manufacturer 2
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Beijing Choice Electronic Technololgy Co., Ltd. Beijing Beijing Repacker / relabeller 30
Hong Qiangxing (Shen Zhen) Electronics Limited Shenzhen Guangdong Contract manufacturer 19
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Guangzhou Xinbo Electronic Co., Ltd. Guangzhou Guangdong Contract manufacturer 18
Drtv Asia Ltd Panyu Guangzhou Guangdong Specification developer 16
Hebei Tuosite Technology Co., Ltd. Shijiazhuang Hebei Manufacturer 14

Showing 12 of 32. All 32 manufacturers in China registered for Stimulator, Nerve, Transcutaneous, For Pain Relief

Record

Regulatory record for QuadraTENS
Listed by BIO-Research Associates, Inc., United States
FDA product code GZJ
Device type Stimulator, Nerve, Transcutaneous, For Pain Relief
Device class Class 2
Regulation 21 CFR 882.5890
Establishment Complaint-file establishment, Manufacturer
510(k) K061799
Record published 2023-06-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for QuadraTENS
Catalogue number Size Status
Unit In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GEM-Stim Gemore Technology Co., Ltd. 66
Belifu Hong Qiangxing (Shen Zhen) Electronics Limited 55
Neocarbon Hong Qiangxing (Shen Zhen) Electronics Limited 38
Domas Hong Qiangxing (Shen Zhen) Electronics Limited 30
Avazzia Avazzia, Inc. 29
NeuroMD Hong Qiangxing (Shen Zhen) Electronics Limited 24
Mastogo Hong Qiangxing (Shen Zhen) Electronics Limited 18
EmeTerm WAT Medical Technology Inc. 17
Stimease Hong Qiangxing (Shen Zhen) Electronics Limited 15
Xpoint Hong Qiangxing (Shen Zhen) Electronics Limited 15
Globus Domino SRL 13
Omega Hong Qiangxing (Shen Zhen) Electronics Limited 12

Showing 12 of 358. All products under Stimulator, Nerve, Transcutaneous, For Pain Relief

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K061799 2006-08-28
K844618 1985-08-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer