Electro-GEL 128OZ
Electro-Gel provides the conductive contact between the scalp and external electrodes during human electroencephalography and evoked-potential recordings. It reduces electrical impedance at…
Electro-Gel provides the conductive contact between the scalp and external electrodes during human electroencephalography and evoked-potential recordings. It reduces electrical impedance at the skin-electrode interface so that signals can pass to the recording equipment in clinical or research use.
The water-miscible gel uses sodium chloride as its conductor. Thickening agents, humectants, emulsifiers and preservatives are combined in an aqueous base to form the gel. It is intended for external electrodes, including recessed electrodes used in scalp recording.
Contact and Storage
Skin contact must not exceed eight hours in one recording session. The 128 ounce container is one of the available jar sizes. The gel has a one-year shelf life when kept tightly closed at room temperature.
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 | Electro-CAP Intl., Inc., United States |
|---|---|
| FDA product code | GYB |
| Device type | Media, Electroconductive |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1275 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K111717 |
| Record published | 2016-09-23 |
| Record revised | 2018-10-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E11 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111717 | 2012-01-05 |
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.