LSI Silver Self Adhesive, Disposable Electrodes
1.5"x 2.5" Oval Foam
47manufacturers in China registered for this device type
37catalogue numbers in this listing
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 | Drive DeVilbiss Healthcare, United States |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Repacker / relabeller |
| 510(k) | K050469 |
| Record published | 2016-09-01 |
| Record revised | 2026-05-27 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Master carton of 50, inner carton of 10, pack of 10 |
| Distribution end date | 2018-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 203-565 | In distribution | ||
| 300-124 | In distribution | ||
| 203-836 | In distribution | ||
| 300-153 | In distribution | ||
| 300-137 | In distribution | ||
| 300-127 | In distribution | ||
| 300-171 | 4 | In distribution | |
| 300-173 | 4 | In distribution | |
| 300-149 | In distribution | ||
| 300-128 | In distribution | ||
| 300-123 | In distribution | ||
| 300-138 | In distribution | ||
| 300-130 | In distribution | ||
| 300-174 | 4 | In distribution | |
| 203-566 | In distribution | ||
| 203-567 | In distribution | ||
| 300-129 | In distribution | ||
| 300-151 | In distribution | ||
| 300-155 | Withdrawn | ||
| 300-168 | Withdrawn | ||
| 300-154 | Withdrawn | ||
| 300-159 | Withdrawn | ||
| 300-174 | Withdrawn | ||
| 300-156 | Withdrawn | ||
| 300-158 | Withdrawn | ||
| 300-157 | Withdrawn | ||
| 300-173 | Withdrawn | ||
| 300-165 | Withdrawn | ||
| 300-166 | Withdrawn | ||
| 300-170 | Withdrawn | ||
| 300-162 | Withdrawn | ||
| 300-163 | Withdrawn | ||
| 300-171 | Withdrawn | ||
| 300-169 | Withdrawn | ||
| 300-160 | Withdrawn | ||
| 300-167 | Withdrawn | ||
| 300-161 | 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 |
| 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
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| NAImco Inc dba Richmar Inc | 510(k) number | 2009-11-30 | Class II | Unknown/Undetermined by firm | Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. | 209860 electrodes | 2013-09-03 |
| NAImco Inc dba Richmar Inc | 510(k) number | 2009-11-30 | Class II | Unknown/Undetermined by firm | Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. | 25860 electrodes | 2013-09-03 |
| NAImco Inc dba Richmar Inc | 510(k) number | 2009-11-30 | Class II | Unknown/Undetermined by firm | Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. | 129400 electrodes | 2013-09-03 |
| NAImco Inc dba Richmar Inc | 510(k) number | 2009-11-30 | Class II | Unknown/Undetermined by firm | Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. | 56980 electrodes | 2013-09-03 |
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.