Compex

Compex LT

Registry build 21.09.26
8manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GZI
Manufacturer City Province Registered as Device types
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Suzhou Fast ATM Electric Co., Ltd. Suzhou Jiangsu Contract manufacturer 2
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Netop Industrial Company Limited Dongguan Guangdong Manufacturer 14
Devon Medical Products (Jiangsu) Ltd Nantong Jiangsu Repacker / relabeller 12
Guangzhou Longest Medical Technology Co., Ltd. Guangzhou Guangdong Manufacturer 9
Shenzhen XFT Medical Limited Shenzhen Guangdong Manufacturer 8
Xemis Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Compex
Listed by DJO, LLC, United States
FDA product code GZI
Device type Stimulator, Neuromuscular, External Functional
Device class Class 2
Regulation 21 CFR 882.5810
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-08-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Compex
Catalogue number Size Status
CX182WI04 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
L300 Go System Bioness Medical, Inc. 22
RT300 Restorative Therapies Inc. 20
H200 Wireless System Bioness Medical, Inc. 20
Chattanooga DJO, LLC 17
Cionic Cionic 6
L100 Go System Bioness Medical, Inc. 4
MyndStep Myndtec Inc 4
ReGrasp Rehabtronics, Inc. 4
XFT Shenzhen XFT Medical Limited 3
RT200 Restorative Therapies Inc. 2
RehaStim 2 Hasomed Gmbh 2
H200 Wireless Bioness Medical, Inc. 2

Showing 12 of 53. All products under Stimulator, Neuromuscular, External Functional

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