GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Medtronic Vascular, Empi and Aspect Medical Systems, Inc..

440
Total
440
Cleared
127d
Avg days
1976
Since
440 devices
73–96 of 440
Cleared Jun 01, 2018
Silverwear Silver Pro Garment Device
K171798
Media Plus, LLC
Neurology · 350d
Cleared May 22, 2018
Reusable and Self-Adhesive Electrodes
K180773
Shaoxing Dongzhi Electrical Technology Co., Ltd.
Neurology · 60d
Cleared May 18, 2018
EEG-Now
K180524
Encephalodynamics, Inc.
Neurology · 80d
Cleared Apr 27, 2018
NeuroCap
K172866
Memory MD, Inc.
Neurology · 219d
Cleared Apr 19, 2018
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
K172887
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 210d
Cleared Mar 21, 2018
Element System with IBT Electrodes
K173571
Infinite Biomedical Technologies, LLC
Neurology · 121d
Cleared Feb 28, 2018
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
K173186
Everyway Medical Instruments Co.,Ltd
Neurology · 149d
Cleared Jan 10, 2018
Electrodes with snap / Electrodes with pigtail
K171722
Shenzhen Konmed Technology Co., Ltd.
Neurology · 212d
Cleared Jan 05, 2018
Electrodes with silver conductive
K171721
Shenzhen Konmed Technology Co., Ltd.
Neurology · 207d
Cleared Dec 21, 2017
Ives MR Conditional Cup Electrode
K171102
Ives Egg Solutions
Neurology · 252d
Cleared Dec 13, 2017
Adhesive Electrodes
K171381
Shenzhen Quality Medical Technology Co.,Ltd
Neurology · 216d
Cleared Dec 01, 2017
MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172503
Rhythmlink International, LLC
Neurology · 105d
Cleared Nov 13, 2017
Disposable Snap Electrode
K172703
Embla Systems
Neurology · 67d
Cleared Aug 21, 2017
Ceribell Instant EEG Headband
K171459
Ceribell, Inc.
Neurology · 95d
Cleared May 08, 2017
Adhesive Electrodes
K170744
Reno Medical , Ltd.
Neurology · 59d
Cleared Apr 28, 2017
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
K162460
Wavi Co.
Neurology · 238d
Cleared Apr 14, 2017
Complete Control System
K162891
Coapt, LLC
Neurology · 179d
Cleared Apr 11, 2017
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
K163547
Neurovirtual USA, Inc.
Neurology · 116d
Cleared Oct 30, 2016
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
K161282
Medico Electrodes International , Ltd.
Neurology · 177d
Cleared Oct 19, 2016
TENS Electrodes
K160081
Cathay Manufacturing Corp.
Neurology · 278d
Cleared Aug 11, 2016
Adhesive Electrodes
K160138
Gmdasz Manufacturing Co., Ltd.
Neurology · 203d
Cleared Mar 21, 2016
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
K153019
Bio Protech, Inc.
Neurology · 158d
Cleared Mar 08, 2016
Mailuokang Self-adhesive Electrode
K152815
Shenzhen Mailuokang Technology Co., Ltd.
Neurology · 162d
Cleared Feb 18, 2016
Ennova Self-adhesive Electrode
K152648
Suzhou Ennova Electronics Technology Co.,Ltd
Neurology · 155d