SAC2 – Electrode Cream
SAC2 Electrode Cream provides a conductive connection between the scalp and external recessed electrodes during clinical or research EEG and evoked-potential recordings. It reduces…
SAC2 Electrode Cream provides a conductive connection between the scalp and external recessed electrodes during clinical or research EEG and evoked-potential recordings. It reduces impedance at the electrode-to-skin interface to support acquisition of the electrical signal.
The water-based cream contains sodium chloride and potassium chloride as conductive ingredients, with powders, thickening agents and humectants. It is supplied as a light-grey opaque cream in an aluminium tube for application with recording electrodes.
Recording Use
The cream is intended only for external use with recording electrodes. Its role is electrical contact for signal recording rather than delivery of stimulation or treatment energy.
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 | Spes Medica Srl, Italy |
|---|---|
| FDA product code | GYB |
| Device type | Media, Electroconductive |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1275 |
| 510(k) | K192606 |
| Record published | 2020-01-27 |
| Record revised | 2025-02-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SAC2-10 | 10 | 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 |
|---|---|
| K212326 | 2021-12-01 |
| K192606 | 2020-01-17 |
| K190050 | 2019-07-19 |
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.