Product Code: GYB FDA class 2 21 CFR 882.1275

Media, Electroconductive

Neurology

Electroconductive Media is a conductive gel or paste applied between recording electrodes and the skin or scalp to reduce impedance and improve signal quality during neurological diagnostic procedures such as EEG or EMG. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GYB under regulation 21 CFR 882.1275 in the Neurology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: GYB
Device Class: FDA class 2
Regulation Number: 882.1275
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 69 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243749	Jmoon Conductive Gel	Apr 08, 2025	Substantially Equivalent	Shenzhen Ulike Smart Electronics Co., Ltd.
K220735	Avologi Gel Primer (Model: Av25)	Sep 15, 2023	Substantially Equivalent	Premier North America, Inc.
K222770	Conductive Gel	Dec 13, 2022	Substantially Equivalent	Top-Rank Health Care Co., Ltd.
K221724	Conductive Gel	Sep 23, 2022	Substantially Equivalent	Tone-A-Matic International, Inc.
K212325	EEG-acp	Jun 15, 2022	Substantially Equivalent	Somnomedics GmbH
K212326	AC Cream - Conductive paste	Dec 01, 2021	Substantially Equivalent	Spes Medica Srl
K212787	GT5 conductive & abrasive gel	Nov 08, 2021	Substantially Equivalent	Wuhan Greentek Pty , Ltd.
K200402	DR-HO'S Electro Therapy Conductive Gel	Nov 25, 2020	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.
K191975	Elefix V Paste for EEG & EMG	Feb 07, 2020	Substantially Equivalent	Nihon Kohden Corporation
K192606	SAC2 - Electrode Cream	Jan 17, 2020	Substantially Equivalent	Spes Medica Srl
K190050	Tech Dots - Adhesive and conductive gel	Jul 19, 2019	Substantially Equivalent	Spes Medica Srl
K161715	EndyGel	Feb 07, 2017	Substantially Equivalent	Endymed Medical, Ltd.
K161654	NuFACE Gel Primer	Dec 30, 2016	Substantially Equivalent	Carol Cole Company
K111717	ELECTRO-GEL	Jan 05, 2012	Substantially Equivalent	Electro-Cap Intl., Inc.
K032239	THERA-CREAM, MODEL TCT004	Jul 30, 2004	Substantially Equivalent	Prizm Medical, Inc.
K033052	CONDUCTIVE EEG ELECTROLYTE	Dec 17, 2003	Substantially Equivalent	Compumedics USA, Ltd.
K030887	LEKTROGEL, MODEL LK3001	Jun 13, 2003	Substantially Equivalent	Inmed Ltda.
K022494	HOME CARE JELLY	Dec 02, 2002	Substantially Equivalent	Roc Chinese-European Industrial Research Society
K022006	CONDUCTIVE GEL	Sep 13, 2002	Substantially Equivalent	The Dezac Group
K003924	MAVIDON MEDICAL ELECTRODE JELLY	Aug 24, 2001	Substantially Equivalent	Mavidon Medical Products
K002832	CONDUCTIVE GEL FOR ULTRASOUND	Aug 06, 2001	Substantially Equivalent	Skylark Device & Systems Co., Ltd.
K001705	STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF	Jun 29, 2000	Substantially Equivalent	Chester Labs, Inc.
K983964	BATCH #6060 CONDUCTIVE GEL	Dec 09, 1998	Substantially Equivalent	Skylark Device Co., Ltd.
K970694	MODEL 1700, HYDRO PREP	May 14, 1997	Substantially Equivalent	Physiometrix, Inc.
K964737	HYDROPREP GEL	Mar 19, 1997	Substantially Equivalent	D.O. Weaver Co.
K962681	ECOGEL 300 TENS GEL	Oct 04, 1996	Substantially Equivalent	Eco-Med Pharmaceuticals, Inc.
K955597	MEDI-TRACE DEFIB PADS	Jul 09, 1996	Substantially Equivalent	Graphic Controls Corp.
K944599	GRAHAM-FIELD CONDUCTIVE ECG SPRAY	May 07, 1996	Substantially Equivalent	Chester Labs, Inc.
K944598	GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL	May 07, 1996	Substantially Equivalent	Chester Labs, Inc.
K944600	GRAHAM-FIELD SALINE ELECTROLYTE GEL	Nov 20, 1995	Substantially Equivalent	Chester Labs, Inc.
K933799	TEN-20 CONDUCTIVE PASTE GEL	May 27, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K933797	OMNI PREP GEL	May 17, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K933804	LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL	Mar 22, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K925466	CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON	Aug 26, 1993	Substantially Equivalent	Uni-Patch, Inc.
K904377	ELECTROCONDUCTIVE MEDIA	Nov 15, 1991	Substantially Equivalent	Henley Intl.
K904889	TENS CONDUCTIVE MEDIA PAD	May 14, 1991	Substantially Equivalent	Creative Design Systems, Inc.
K901630	CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)	Jul 16, 1990	Substantially Equivalent	Henley Intl.
K893604	TENS PREP	Nov 21, 1989	Substantially Equivalent	Smith & Nephew United, Inc.
K883149	TEN20 CONDUCTIVE	Sep 28, 1988	Substantially Equivalent	Weaver & Co.
K872045	CONDUCTIVITY GEL	Jul 15, 1987	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K871913	CONDUCTIVITY GEL	Jul 15, 1987	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K862799	SKIN PURE	Nov 13, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K860210	ELEFIX ELECTRODE CREAM	Jul 01, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K852956	CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION	Aug 09, 1985	Substantially Equivalent	Parker Laboratories, Inc.
K841871	LIQUA-SONIC GEL	Mar 14, 1985	Substantially Equivalent	Chester Labs, Inc.
K833172	ECG-GEL ELECTRODE GEL	Nov 21, 1983	Substantially Equivalent	Whs Products, Inc.
K821539	MEDICOTEST ELECTRODE PASTE	Jul 02, 1982	Substantially Equivalent	Medicotest, Inc.
K820991	KENZ-GELECT GEL PAD	Apr 26, 1982	Substantially Equivalent	Suzuken Co., Ltd.
K812263	KENZ-GELECT	Nov 02, 1981	Substantially Equivalent	Suzuken Co., Ltd.
K812284	ZEE ELECTRODE-GEL	Sep 08, 1981	Substantially Equivalent	Zee Medical Products Co., Inc.
K802647	ECA GEL PROUDUCT REFORMULATION	Jan 08, 1981	Substantially Equivalent	Vanaray Laboratories, Inc.
K803151	ECG & ULTRASOUND GELS, CREAMS & LOTION	Dec 30, 1980	Substantially Equivalent	Abco Dealers, Inc.
K802658	RODEL ELECTRODERM PADS	Dec 30, 1980	Substantially Equivalent	Rodel Products Corp.
K802648	UCA CREAM PRODUCT REFORMULATION	Nov 26, 1980	Substantially Equivalent	Vanaray Laboratories, Inc.
K802650	UCA LOTION PRODUCT REFORMULATION	Nov 12, 1980	Substantially Equivalent	Vanaray Laboratories, Inc.
K802649	UCA GEL PRODUCT REFORMAULATION	Nov 12, 1980	Substantially Equivalent	Vanaray Laboratories, Inc.
K801383	ECA CREAM REFORMULATION	Jun 17, 1980	Substantially Equivalent	Vanaray Laboratories, Inc.
K792491	ECA CREAM	Feb 05, 1980	Substantially Equivalent	Vanaray Laboratories, Inc.
K792488	ECA GEL	Feb 05, 1980	Substantially Equivalent	Vanaray Laboratories, Inc.
K791013	SPECTRA R PAD	Sep 17, 1979	Substantially Equivalent	Parker Laboratories, Inc.
K790818	MEDI-TRACE EEG CREME	Jun 05, 1979	Substantially Equivalent	Graphic Controls Corp.
K781493	EEG GEL	Apr 17, 1979	Substantially Equivalent	Graphic Controls Corp.
K782055	CREAM, SIGNA	Mar 21, 1979	Substantially Equivalent	Parker Laboratories, Inc.
K781989	OMNIPREP	Dec 15, 1978	Substantially Equivalent	Weaver & Co.
K780973	SIGNAPAD	Jul 27, 1978	Substantially Equivalent	Parker Laboratories, Inc.
K780631	NDM INFANT ECG PACKPAD	May 03, 1978	Substantially Equivalent	New Dimensions IN Medicine, Inc.
K771893	DISPOSABLE ELHCTRODE	Nov 02, 1977	Substantially Equivalent	Chase Medical Services
K770623	CONDUCTIVE CREAM-500	Apr 08, 1977	Substantially Equivalent	Graphic Controls Corp.
K770622	CONDUCTIVITY GEL W/POTASSIUM CHLORIDE	Apr 07, 1977	Substantially Equivalent	Graphic Controls Corp.