FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K161654 |
Carol Cole Company |
NuFACE Gel Primer |
12/30/2016 |
K944599 |
CHESTER LABS, INC. |
GRAHAM-FIELD CONDUCTIVE ECG SPRAY |
05/07/1996 |
K944598 |
CHESTER LABS, INC. |
GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL |
05/07/1996 |
K001705 |
CHESTER LABS, INC. |
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF |
06/29/2000 |
K033052 |
COMPUMEDICS USA, LTD. |
CONDUCTIVE EEG ELECTROLYTE |
12/17/2003 |
K964737 |
D.O. WEAVER CO. |
HYDROPREP GEL |
03/19/1997 |
K962681 |
ECO-MED PHARMACEUTICALS, INC. |
ECOGEL 300 TENS GEL |
10/04/1996 |
K111717 |
ELECTRO-CAP INTL., INC. |
ELECTRO-GEL |
01/05/2012 |
K161715 |
EndyMed Medical Ltd. |
EndyGel |
02/07/2017 |
K955597 |
GRAPHIC CONTROLS CORP. |
MEDI-TRACE DEFIB PADS |
07/09/1996 |
K200402 |
Guangzhou Xinbo Electronic Co., Ltd. |
DR-HO'S Electro Therapy Conductive Gel |
11/25/2020 |
K030887 |
INMED LTDA. |
LEKTROGEL, MODEL LK3001 |
06/13/2003 |
K003924 |
MAVIDON MEDICAL PRODUCTS |
MAVIDON MEDICAL ELECTRODE JELLY |
08/24/2001 |
K191975 |
Nihon Kohden Corporation |
Elefix V Paste for EEG & EMG |
02/07/2020 |
K970694 |
PHYSIOMETRIX, INC. |
MODEL 1700, HYDRO PREP |
05/14/1997 |
K220735 |
Premier North America Inc. |
Avologi Gel Primer (Model: Av25) |
09/15/2023 |
K032239 |
PRIZM MEDICAL, INC. |
THERA-CREAM, MODEL TCT004 |
07/30/2004 |
K022494 |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
HOME CARE JELLY |
12/02/2002 |
K002832 |
SKYLARK DEVICE & SYSTEMS CO., LTD |
CONDUCTIVE GEL FOR ULTRASOUND |
08/06/2001 |
K983964 |
SKYLARK DEVICE CO., LTD. |
BATCH #6060 CONDUCTIVE GEL |
12/09/1998 |
K212325 |
SOMNOmedics GmbH |
EEG-acp |
06/15/2022 |
K212326 |
Spes Medica S.r.l |
AC Cream - Conductive paste |
12/01/2021 |
K192606 |
Spes Medica S.r.l. |
SAC2 - Electrode Cream |
01/17/2020 |
K190050 |
Spes Medica S.r.l. |
Tech Dots - Adhesive and conductive gel |
07/19/2019 |
K022006 |
THE DEZAC GROUP |
CONDUCTIVE GEL |
09/13/2002 |
K221724 |
Tone-A-Matic International Inc. |
Conductive Gel |
09/23/2022 |
K222770 |
Top-Rank Health Care Co.,Ltd. |
Conductive Gel |
12/13/2022 |
K212787 |
Wuhan Greentek Pty Ltd. |
GT5 conductive & abrasive gel |
11/08/2021 |