GYB · Media, Electroconductive
Neurology · 21 CFR 882.1275 · Class 2
Overview
| Product Code | GYB |
|---|---|
| Device Name | Media, Electroconductive |
| Regulation | 21 CFR 882.1275 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 69)
Showing 20 most recent of 69 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. | Apr 8, 2025 | SESE |
| K220735 | Avologi Gel Primer (Model: Av25) | Premier North America, Inc. | Sep 15, 2023 | SESE |
| K222770 | Conductive Gel | Top-Rank Health Care Co., Ltd. | Dec 13, 2022 | SESE |
| K221724 | Conductive Gel | Tone-A-Matic International, Inc. | Sep 23, 2022 | SESE |
| K212325 | EEG-acp | Somnomedics GmbH | Jun 15, 2022 | SESE |
| K212326 | AC Cream - Conductive paste | Spes Medica Srl | Dec 1, 2021 | SESE |
| K212787 | GT5 conductive & abrasive gel | Wuhan Greentek Pty , Ltd. | Nov 8, 2021 | SESE |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | Nov 25, 2020 | SESE |
| K191975 | Elefix V Paste for EEG & EMG | Nihon Kohden Corporation | Feb 7, 2020 | SESE |
| K192606 | SAC2 - Electrode Cream | Spes Medica Srl | Jan 17, 2020 | SESE |
| K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | Jul 19, 2019 | SESE |
| K161715 | EndyGel | Endymed Medical, Ltd. | Feb 7, 2017 | SESE |
| K161654 | NuFACE Gel Primer | Carol Cole Company | Dec 30, 2016 | SESE |
| K111717 | ELECTRO-GEL | Electro-Cap Intl., Inc. | Jan 5, 2012 | SESE |
| K032239 | THERA-CREAM, MODEL TCT004 | Prizm Medical, Inc. | Jul 30, 2004 | SESE |
| K033052 | CONDUCTIVE EEG ELECTROLYTE | Compumedics USA, Ltd. | Dec 17, 2003 | SESE |
| K030887 | LEKTROGEL, MODEL LK3001 | Inmed Ltda. | Jun 13, 2003 | SESE |
| K022494 | HOME CARE JELLY | Roc Chinese-European Industrial Research Society | Dec 2, 2002 | SESE |
| K022006 | CONDUCTIVE GEL | The Dezac Group | Sep 13, 2002 | SESE |
| K003924 | MAVIDON MEDICAL ELECTRODE JELLY | Mavidon Medical Products | Aug 24, 2001 | SESE |
Top Applicants
- Vanaray Laboratories, Inc. — 7 clearances
- Chester Labs, Inc. — 5 clearances
- Graphic Controls Corp. — 5 clearances
- Parker Laboratories, Inc. — 4 clearances
- Cadwell Laboratories, Inc. — 3 clearances
