Three Degrees
Rectangular shape TENS/EMS Electrode Pads includes specification of 10*100, 15*40, 17*70, 20*40, 20*80, 20*100, 25*35, 30*50, 30*60, 30*70, 30*90, 32*95, 35*45, 35*50, 35*70, 35*82, 40*53,…
Rectangular shape TENS/EMS Electrode Pads includes specification of 10*100, 15*40, 17*70, 20*40, 20*80, 20*100, 25*35, 30*50, 30*60, 30*70, 30*90, 32*95, 35*45, 35*50, 35*70, 35*82, 40*53, 40*60, 40*70, 40*90, 40*100, 45*60, 45*70, 45*90, 45*95, 46*73, 50*55, 50*60, 50*70, 50*80, 50*90, 50*100, 52*78, 53*210, 55*90, 50*96, 55*100, 60*70, 60*80, 60*90, 60*100, 62*96, 65*140, 68*88, 70*70, 70*100, 70*110, 70*130, 70*140, 73*160, 90*130, 95*100, 95*195, 96*162, 98*220, 100*150, 110*150, 115*180, 150*200.
Who Else Makes It
Concentrated in Guangdong (29), Jiangsu (4), Zhejiang (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Shenzhen Zifound Infonet Technology Co., Ltd. | Shenzhen, Guandong | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
Showing 12 of 47. All 47 manufacturers in China registered for Electrode, Cutaneous
Record
| Listed by | Dong Guan OU Kang Electronics Co., Ltd., China |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Manufacturer |
| 510(k) | K181234 |
| Record published | 2023-08-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rectangular | In distribution | |
| Square | In distribution | |
| Hand*3+Square*1+Ellipse*1 | In distribution | |
| Square50*50mm*3+Rectangle50*100mm*3 | In distribution | |
| 5*5 snap | In distribution | |
| Oval | In distribution | |
| Hand shape | In distribution | |
| Circular | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 455 |
| waveguard | Eemagine Medical Imaging Solutions Gmbh | 166 |
| Espire Elbow Hybrid | College Park Industries | 138 |
| Technomed Europe | Technomed Engineering B.V. | 126 |
| Cadwell | Technomed Engineering B.V. | 111 |
| The Electrode Store | Impulse Technology LLC | 109 |
| Electrode, Cutaneous | Gmdasz Manufacturing Co., Ltd. | 99 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 93 |
| AdvanTrode | Pepin Manufacturing, Inc. | 78 |
| Uni-Patch | Cardinal Health | 77 |
| Alpha | WillowWood Global LLC | 68 |
| Espire Elbow Pro | College Park Industries | 67 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181234 | 2018-08-07 |
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.