Electrode, Cutaneous
PG479/50W/US are round-shaped disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel…
PG479/50W/US are round-shaped disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The electrodes Ø 50 mm are equipped with a 10 cm long cable, with 2mm socket. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient’s skin. The electrodes are non-sterile and for single patient use only. Latex free.
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 | Fiab SPA, Italy |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K091163 |
| Record published | 2020-06-12 |
| Record revised | 2021-10-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 35 °C; Storage environment humidity 20 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PG471/50W/US | 4 | In distribution | |
| PG470/500/US | 4 | In distribution | |
| PG479/75W/US | 4 | In distribution | |
| PG477W/US | 4 | In distribution | |
| PG474W/US | 4 | In distribution | |
| PG479/50W/US | 4 | In distribution | |
| PG479/32W/US | 4 | In distribution | |
| PG471W/US | 4 | 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 |
|---|---|
| K091163 | 2009-07-22 |
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.