GEM-Stim
Clinical type High Voltage Pulsed Galvanic Stimulator
32manufacturers in China registered for this device type
66catalogue numbers in this listing
5510(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 | Gemore Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | GZJ |
| Device type | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K120569 |
| Record published | 2016-09-23 |
| Record revised | 2023-06-02 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| Packaging | Carton of 30, carton of 20, carton of 5, carton of 40, carton of 500 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LW01 | In distribution | |
| GM310TP | In distribution | |
| GM330T | In distribution | |
| GM510T | In distribution | |
| PRO TENS | In distribution | |
| GM384 | In distribution | |
| GM350T | In distribution | |
| Century 2100 | In distribution | |
| GM343HV | In distribution | |
| GM3A40T | In distribution | |
| GM333HV | In distribution | |
| GM3A10T | In distribution | |
| GM310T | In distribution | |
| GM310PP | In distribution | |
| GM303HV | In distribution | |
| GM340PP | In distribution | |
| GM383HV | In distribution | |
| 13th TENS TS-1211 | In distribution | |
| GM313HV | In distribution | |
| GM3A50T | In distribution | |
| GM3A50T | In distribution | |
| GM511TE | In distribution | |
| GM300PP | In distribution | |
| GM353HV | In distribution | |
| GM340T | In distribution | |
| GM350PP | In distribution | |
| GM340TP | In distribution | |
| TX-3 | In distribution | |
| GM380T | In distribution | |
| GM394 | In distribution | |
| GM3A00T | In distribution | |
| GM510TE | In distribution | |
| GM530T | In distribution | |
| GM320T | In distribution | |
| GM323HV | In distribution | |
| GM330PP | In distribution | |
| GM540TE | In distribution | |
| GM320TP | In distribution | |
| GM310TE | In distribution | |
| GM390T | In distribution | |
| TX-2M | In distribution | |
| GM520T | In distribution | |
| GM320T(3) | In distribution | |
| GM3A20T | In distribution | |
| GM390TE | In distribution | |
| GM350TE | In distribution | |
| GM380PP | In distribution | |
| GM520TE | In distribution | |
| GM330TE | In distribution | |
| Arista 2000 | In distribution | |
| GM3A30T | In distribution | |
| GM350PP | In distribution | |
| GM304 | In distribution | |
| GM340TE | In distribution | |
| GM540T | In distribution | |
| GM380TE | In distribution | |
| GM511T | In distribution | |
| GM390PP | In distribution | |
| GM330TP | In distribution | |
| GM530TE | In distribution | |
| GM300T | In distribution | |
| GM393HV | In distribution | |
| GM300TE | In distribution | |
| GM320PP | In distribution | |
| GM504 | In distribution | |
| GM3A50T(0) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 12 |
Showing 12 of 358. All products under Stimulator, Nerve, Transcutaneous, For Pain Relief
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122948 | 2012-12-21 |
| K120569 | 2012-07-20 |
| K042559 | 2004-11-17 |
| K032994 | 2003-12-16 |
| K032720 | 2003-12-10 |
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.