Uni-Patch
S Series Stimulating Electrodes,616SB, Silver Carbon, Aloe Vera Gel
47manufacturers in China registered for this device type
77catalogue numbers in this listing
4recalls on this code
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 | Cardinal Health, United States |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-07-04 |
| Record revised | 2025-12-31 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: No; |
| Packaging | Case of 1200, case of 999, case of 1000, case of 800, case of 400, case of 600 |
| Sizes | Width 1.75 to 13 in; length 1.5 to 7 in; outer diameter 1.25 to 2.75 in; height 0.625 in |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EP85860 | Outer Diameter 1.25 in | 4 | In distribution |
| EP85867 | Length 2 in | 4 | In distribution |
| EP84264 | Length 2 in | 4 | In distribution |
| EP85845 | Length 1.5 in | 4 | In distribution |
| EP84266 | Length 3.5 in | 4 | In distribution |
| EP85785 | Width 2.5 in | 4 | In distribution |
| EP84265 | Width 2 in | 4 | In distribution |
| EP84262 | Outer Diameter 2 in | 4 | In distribution |
| EP85881 | Outer Diameter 2 in | 4 | In distribution |
| EP85863 | Width 2 in | 4 | In distribution |
| EP85869 | Outer Diameter 2.75 in | 4 | In distribution |
| EP85877 | Outer Diameter 1.25 in | 4 | In distribution |
| EP85879 | Width 2 in | 4 | In distribution |
| ES82170 | Length 1.5 in | In distribution | |
| EP85790 | Width 2 in | 4 | In distribution |
| EP84267 | Outer Diameter 2 in | 4 | In distribution |
| EP85883 | Width 3.5 in | 4 | In distribution |
| EP85887 | Outer Diameter 2.75 in | 4 | In distribution |
| EP84261 | Width 2 in | 4 | In distribution |
| EP85850 | Width 2 in | 4 | In distribution |
| EC89440 | Width 1.75 in | 4 | In distribution |
| EP84750 | Length 1.5 in | In distribution | |
| EP85861 | Outer Diameter 2 in | 4 | In distribution |
| ES82060 | Width 2.5 in | 4 | In distribution |
| ES82200 | Length 4 in | 4 | Withdrawn |
| EP85345 | Length 2 in | 4 | Withdrawn |
| EP85873 | Width 2.5 in | 4 | Withdrawn |
| 634 | 40 | Withdrawn | |
| EP85350 | Outer Diameter 2.75 in | 4 | Withdrawn |
| EP84772 | Width 2 in | 4 | Withdrawn |
| EP85835 | Length 2 in | 4 | Withdrawn |
| EC89041 | Width 2.5 in | 40 | Withdrawn |
| EP84770 | Width 2 in | 4 | Withdrawn |
| EP84720 | Length 6 in | Withdrawn | |
| EP84604 | Length 6 in | Withdrawn | |
| EP84625 | Outer Diameter 2 in | 4 | Withdrawn |
| EP85040 | Width 2 in | 4 | Withdrawn |
| EP85795 | Outer Diameter 1.25 in | 4 | Withdrawn |
| EP85800 | Outer Diameter 1.25 in | 4 | Withdrawn |
| EP85840 | Width 3.5 in | 4 | Withdrawn |
| EP85780 | Length 2 in | 4 | Withdrawn |
| EP85875 | Length 2 in | 4 | Withdrawn |
| EP84580 | Width 3 in | 2 | Withdrawn |
| EC89001 | Length 2.25 in | 32 | Withdrawn |
| ET88020 | Width 2.25 in | 48 | Withdrawn |
| EP84690 | Length 6 in | Withdrawn | |
| PC90030 | Length 1.5 in | 20 | Withdrawn |
| EC89150 | Length 1.5 in | 4 | Withdrawn |
| EC89016 | Width 2.5 in | 16 | Withdrawn |
| EP85775 | Width 2 in | 4 | Withdrawn |
| ES82180 | Length 2 in | 4 | Withdrawn |
| EP85360 | Length 4 in | 4 | Withdrawn |
| EP84590 | Width 6 in | 2 | Withdrawn |
| EC89350 | Width 4 in | 4 | Withdrawn |
| EC89375 | Length 2 in | 4 | Withdrawn |
| EP85805 | Outer Diameter 2 in | 4 | Withdrawn |
| EP85340 | Outer Diameter 2 in | 4 | Withdrawn |
| EP84850 | Outer Diameter 2.75 in | 4 | Withdrawn |
| EC89380 | Width 1.75 in | 4 | Withdrawn |
| EP84820 | Outer Diameter 2 in | 4 | Withdrawn |
| EP84910 | Length 2 in | 4 | Withdrawn |
| ES82260 | Width 1.75 in | 40 | Withdrawn |
| EP84699 | Width 2.5 in | 4 | Withdrawn |
| EP84068 | Width 2.5 in | Withdrawn | |
| EC89465 | Length 1.75 in | 4 | Withdrawn |
| EC89260 | Width 2 in | 4 | Withdrawn |
| PC91000 | Length 3.5 in | 4 | Withdrawn |
| EC89270 | Length 2 in | 4 | Withdrawn |
| EP85224 | Width 4 in | Withdrawn | |
| EP85770 | Outer Diameter 2.75 in | 4 | Withdrawn |
| EP85765 | Outer Diameter 2 in | 4 | Withdrawn |
| EP84599 | Length 2 in | 4 | Withdrawn |
| PC90060 | Length 2 in | 4 | Withdrawn |
| EC89455 | Length 1.75 in | 40 | Withdrawn |
| EP85825 | Outer Diameter 2.75 in | 4 | Withdrawn |
| EC89200 | Width 4 in | 4 | Withdrawn |
| PC90035 | Length 1.75 in | 8 | Withdrawn |
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 |
| Alpha | WillowWood Global LLC | 68 |
| Espire Elbow Pro | College Park Industries | 67 |
| Natus | Natus Neurology Incorporated | 66 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-02-09 | Class II | Employee error | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor | 28,138 pouches | 2013-01-03 |
| 2012-02-09 | Class II | Employee error | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor | 3290 | 2013-01-03 |
| 2012-02-09 | Class II | Employee error | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor | 3594 pouches | 2013-01-03 |
| 2012-02-09 | Class II | Employee error | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor | 2,014 pouches | 2013-01-03 |
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.