Flex-IT Retail
device + electrodes
32manufacturers in China registered for this device type
1catalogue number
3510(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.
| 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
| Listed by | Emsi, United States |
|---|---|
| FDA product code | GZJ |
| Device type | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| 510(k) | K071869 |
| Record published | 2016-09-02 |
| Record revised | 2023-06-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FLEI0001R | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K090717 | 2009-05-08 |
| K083030 | 2009-02-05 |
| K071869 | 2008-03-07 |
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.