Electrically Conductive Gel (ECG)
Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Ever Strong Manufacturing Ltd | Dongguan | Guangdong | Contract manufacturer | 8 |
| Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 6 |
| Praywise Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Wuhan Greentek PTY Ltd. | Wuhan | Hubei | Manufacturer | 3 |
Record
| Listed by | Dynarex Corp., United States |
|---|---|
| FDA product code | GYB |
| Device type | Media, Electroconductive |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1275 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K962681 |
| Record published | 2021-02-09 |
| Record revised | 2024-10-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Packaging | Pack of 72, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1239 | In distribution | |
| 1240 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pharmaceutical Innovations | Pharmaceutical Innovations, Inc. | 34 |
| NuFACE | Nuface | 11 |
| Ten20 Conductive Paste | D. O. Weaver AND Company | 6 |
| Alpha-Stim | Parker Laboratories, Inc. | 4 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 4 |
| Ecogel 300 | Eco-Med Pharmaceutical Inc | 4 |
| Elefix | Nihon Kohden Corp. | 4 |
| Compumedics Quik-Gel | Compumedics Limited | 4 |
| Signaspray | Parker Laboratories, Inc. | 3 |
| Rochester | Rochester Electro Medical, Inc. | 3 |
| Covidien | Cardinal Health | 3 |
| Jmoon | Shenzhen Ulike Smart Electronics Co., Ltd. | 3 |
Showing 12 of 60. All products under Media, Electroconductive
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| National Distribution & Contracting Inc | 510(k) number | 2021-08-24 | Class I | Process control | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. | 3 units |
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.