Protocol Solutions
Transcutaneous Electrical Nerve Stimulator, which sends small electrical pulses through the skin to the body's nervous system, for prescription use.
32manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Protocol Solutions LLC, United States |
|---|---|
| FDA product code | GZJ |
| Device type | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K040253 |
| Record published | 2025-09-05 |
| Record revised | 2025-09-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment temperature 15 to 90 % RH; Handling environment atmospheric pressure 700 to 1060 millibar; Storage environment temperature -25 to 60 °C; Storage environment humidity 15 to 90 % RH; Storage environment atmospheric pressure 700 to 1060 millibar |
| Distribution end date | 2025-09-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Nerve Care + | In distribution | |
| Nerve Care + | Withdrawn |
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
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.