L300 Go System

L300 Go System, Right Thigh Stand-Alone

Registry build 21.09.26
33manufacturers in China registered for this device type
11catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (25), Beijing (3), Jiangsu (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IPF
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
Beijing Winkonlaser Technology Limited Beijing Beijing Contract manufacturer 14
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Beijing Beautemax Technology Limited Beijing Beijing Contract manufacturer 13
Suzhou Fast ATM Electric Co., Ltd. Suzhou Jiangsu 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

Showing 12 of 33. All 33 manufacturers in China registered for Stimulator, Muscle, Powered

Record

Regulatory record for L300 Go System
Listed by Bioness Medical, Inc., United States
FDA product code IPF
Device type Stimulator, Muscle, Powered
Device class Class 2
Regulation 21 CFR 890.5850
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K190285
Record published 2025-07-17
Record revised 2020-09-17 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature -25 to 55 °C
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for L300 Go System
Catalogue number Size Status
L4P-5100 In distribution
L4T-5000 In distribution
LG3-5F00 In distribution
L4P-5001 In distribution
LG4-5100 In distribution
LG4-5U00 In distribution
L3P-5D00 In distribution
L4T-5000 In distribution
LG4-1000 In distribution
L3P-5D00 In distribution
LG4-1000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
QB1 Nmes System Motive Health, Inc. 69
MyndMove Myndtec Inc 44
GEM-Stim Gemore Technology Co., Ltd. 38
Chattanooga DJO, LLC 27
ReGrasp Rehabtronics, Inc. 19
Stimulation System Edan Instruments, Inc. 16
e-vive II Nmes System Motive Health, Inc. 16
Motive Knee System Motive Health, Inc. 9
Ness H200® Wireless Hand Rehabilitation System Bioness Medical, Inc. 9
BodyMed Boxout, LLC 8
Everyway Everyway Medical Instruments Co., Ltd. 7
geko Firstkind Ltd 7

Showing 12 of 204. All products under Stimulator, Muscle, Powered

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