ClearanceBrief
Panels › Neurology › Product code GXY · Class 2

Electrode, Cutaneous

Regulation 882.1320

12510(k)s in 12 months (441 all time)
0recalls in 12 months (20 all time)
19recalls that name a 510(k)
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Top companies in GXY

Decided510(k)Device and applicantCode
Jul 8, 2021K203158BioWave BioWraps
Biowave Corporation
GXY
Jun 1, 2021K200942Well-Life Garment Electrodes (GM Series)
Well-Life Healthcare Limited, TW
GXY
Mar 5, 2021K202913NeuroCap (Model DEC22)
Memory MD, Inc.
GXY
Feb 9, 2021K203079MR Conditional Sticky Pad Electrode
Rhythmlink International, LLC
GXY
Feb 3, 2021K192568Jiajian Self-Adhesive Electrode
Wuxi Jiajian Medical Instrument Co., Ltd., CN
GXY
Jun 1, 2020K200540BRAINSTREAM Disposable Deep Cup EEG Electrodes
Conmed Corporation
GXY
May 13, 2020K190118Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
Guangzhou Xinbo Electronic Co., Ltd., CN
GXY
Apr 21, 2020K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Wuhan Greentek Pty , Ltd., CN
GXY
Jan 21, 2020K192564Disposable Gold Cup EEG Electrodes
Dymedix Diagnostics, Inc.
GXY
Sep 4, 2019K191179Myo Plus
Otto Bock Healthcare Products GmbH, AT
GXY
Aug 5, 2019K191225EEG Electrode Template
Rhythmlink International, LLC
GXY
Jul 2, 2019K190617Wrap accessory electrodes
Hi-Dow International, Inc.
GXY
Jun 14, 2019K190700ELECTRODES PAD
Shenzhen Bestpad Technology Development Co., Ltd., CN
GXY
May 24, 2019K191083COMPLETE CONTROL System Gen2
Coapt, LLC
GXY
Apr 4, 2019K190416Dome Electrode
Coapt, LLC
GXY
Apr 3, 2019K180232DAEHAN Disposable CUP Electrodes
Daehan Medical Systems Co., Ltd., KR
GXY
Mar 26, 2019K183154SM Electrodes
Hong Qiangxing (Shenzhen) Electronics Limited, CN
GXY
Jan 17, 2019K182111DL Self-adhesive Electrode
Shaoxing DL Healthcare Co., Ltd., CN
GXY
Nov 29, 2018K182757Espire Elbow Pro, Espire Elbow Hybrid
College Park Industries, Inc.
GXY
Nov 1, 2018K180247DAEHAN Adhesive Surface Electrodes
Daehan Medical Systems Co., Ltd., KR
GXY
Oct 5, 2018K182112Sense System with IBT Electrodes
Infinite Biomedical Technologies, LLC
GXY
Aug 7, 2018K181234Self-adhesive Electrode
Dong Guan OU Kang Electronics Co., Ltd., CN
GXY
Jun 28, 2018K180865ZMI Self-Adhesive Electrodes
Zmi Electronics , Ltd., TW
GXY
Jun 1, 2018K171798Silverwear Silver Pro Garment Device
Media Plus, LLC
GXY
May 22, 2018K180773Reusable and Self-Adhesive Electrodes
Shaoxing Dongzhi Electrical Technology Co., Ltd., CN
GXY
May 18, 2018K180524EEG-Now
Encephalodynamics, Inc.
GXY
Apr 27, 2018K172866NeuroCap
Memory MD, Inc.
GXY
Apr 19, 2018K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
Guangzhou Xinbo Electronic Co., Ltd., CN
GXY
Mar 21, 2018K173571Element System with IBT Electrodes
Infinite Biomedical Technologies, LLC
GXY
Feb 28, 2018K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, &
Everyway Medical Instruments Co.,Ltd, TW
GXY
Jan 10, 2018K171722Electrodes with snap / Electrodes with pigtail
Shenzhen Konmed Technology Co., Ltd., CN
GXY
Jan 5, 2018K171721Electrodes with silver conductive
Shenzhen Konmed Technology Co., Ltd., CN
GXY
Dec 21, 2017K171102Ives MR Conditional Cup Electrode
Ives Egg Solutions
GXY
Dec 13, 2017K171381Adhesive Electrodes
Shenzhen Quality Medical Technology Co.,Ltd, CN
GXY
Dec 1, 2017K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode
Rhythmlink International, LLC
GXY
Nov 13, 2017K172703Disposable Snap Electrode
Embla Systems, CA
GXY
Aug 21, 2017K171459Ceribell Instant EEG Headband
Ceribell, Inc.
GXY
May 8, 2017K170744Adhesive Electrodes
Reno Medical , Ltd., CN
GXY
Apr 28, 2017K162460WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
Wavi Co.
GXY
Apr 14, 2017K162891Complete Control System
Coapt, LLC
GXY
Apr 11, 2017K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
Neurovirtual USA, Inc.
GXY
Oct 30, 2016K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 50
Medico Electrodes International , Ltd., IN
GXY
Oct 19, 2016K160081TENS Electrodes
Cathay Manufacturing Corp., CN
GXY
Aug 11, 2016K160138Adhesive Electrodes
Gmdasz Manufacturing Co., Ltd., CN
GXY
Mar 21, 2016K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
Bio Protech, Inc., KR
GXY
Mar 8, 2016K152815Mailuokang Self-adhesive Electrode
Shenzhen Mailuokang Technology Co., Ltd., CN
GXY
Feb 18, 2016K152648Ennova Self-adhesive Electrode
Suzhou Ennova Electronics Technology Co.,Ltd, CN
GXY
Oct 9, 2015K151693Dr-Ho's Foot Pad Electrode
Drtv Asia, Ltd., CN
GXY
Sep 29, 2015K151576Neon EEG
Incereb, Ltd., IE
GXY
Aug 25, 2015K150971Zekang Self-adhesive Electrode
Jiangsu Zekang Medical Technology Co., Ltd., CN
GXY

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