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Electrode, Cutaneous

FDA product code GXY · 425 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1320
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-04 – 2026-08-27

GXY 2026-08-27

Dexus Prosthetic System (MSL2, MSR2)

Applicant Zhejiang Qiangnao Technology Co.,Ltd

K number K262654

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GXY 2026-07-14

Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

Applicant Ambu A/S

K number K260578

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GXY 2026-06-26

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array

Applicant Cadwell Industries, Inc.

K number K261442

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GXY 2026-06-03

BioWave BioWraps

Applicant Biowave Corporation

K number K261522

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GXY 2026-05-08

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

Applicant Elde Medikal Sanayi ve Ticaret Anonim Sirketi

K number K253237

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GXY 2026-05-07

MR Conditional Cup Electrodes

Applicant Technomed Europe

K number K254183

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GXY 2026-05-01

Tutamen Self Adhesive Electrodes

Applicant Dongguan Tutamen Metalwork Co., Ltd.

K number K252439

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GXY 2026-04-22

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

Applicant Otto Bock Healthcare Products GmbH

K number K253256

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GXY 2026-04-03

Ceribell Brain Monitor Headband

Applicant Ceribell, Inc.

K number K260363

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GXY 2026-03-12

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

Applicant Bionit Labs Srl

K number K260453

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GXY 2026-02-09

Ceribell Instant EEG Headset

Applicant Ceribell, Inc.

K number K254033

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GXY 2025-10-31

Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

Applicant Ceribell, Inc.

K number K251381

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GXY 2025-08-13

Electrotherapy Electrodes

Applicant Baisheng Medical Co., Ltd.

K number K250841

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GXY 2025-03-13

IceCap product line

Applicant Bioserenity Medical Devices Group

K number K243788

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GXY 2025-02-06

Delphi MCS Electrode Cap

Applicant Quantalx Neuroscience, Ltd.

K number K243243

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GXY 2025-01-15

Electrode Pad

Applicant Shenzhen Deliduo Medical Technology Co.,Ltd

K number K241512

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GXY 2025-01-02

Wave Electrode (AE02-60); Wave Electrode (AE02-50)

Applicant Bionit Labs Srl

K number K242326

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GXY 2024-12-13

CAIs Sensor (CAIs-001)

Applicant Brainu Co., Ltd.

K number K241160

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GXY 2024-11-25

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)

Applicant Eemagine Medical Imaging Solutions GmbH

K number K240575

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GXY 2024-08-29

Grass® MR Conditional/CT Cup Electrodes

Applicant Natus Manufacturing Limited

K number K242346

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GXY 2024-06-10

Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)

Applicant Gymmax Technology Shenzhen Co., Ltd.

K number K240108

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GXY 2024-04-15

Glide (91000-GL-X)

Applicant Infinite Biomedical Technologies, LLC

K number K240884

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GXY 2024-03-19

Amydi-med Disposable Non-invasive EEG electrodes

Applicant Shenzhen Amydi-Med Electrics Tech Co., Ltd.

K number K240668

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GXY 2024-01-11

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K number K232995

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GXY 2023-12-19

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)

Applicant Green Island International Tcm Group Limited

K number K221199

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GXY 2023-08-09

Conductive Silicone Rubber Electrode

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K number K231167

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GXY 2023-08-09

Conductive carbon film electrode

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K number K231164

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GXY 2023-08-08

Ceribell Instant EEG Headband

Applicant Ceribell, Inc.

K number K232052

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GXY 2023-03-24

Starly pad

Applicant Shenzhen Xingyuanli Technology Co., Ltd.

K number K221589

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GXY 2023-03-22

Motive™ Electrode

Applicant Cymedica Orthopedics, Inc.

K number K230533

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GXY 2023-03-22

Ceribell Instant EEG Headcap

Applicant Ceribell, Inc.

K number K223086

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GXY 2023-02-02

DeltaScan Patch

Applicant Prolira B.V.

K number K222671

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GXY 2023-02-01

Garment Electrodes

Applicant Tone-A-Matic International, Inc.

K number K222863

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GXY 2023-01-19

Self-adhesive Electrode

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K number K222252

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GXY 2023-01-19

Disposable Non-invasive EEG Sensor

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K number K220448

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GXY 2023-01-11

Alpha Control Liner System (ACLS)

Applicant Coapt

K number K223738

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GXY 2023-01-03

EZ-STIK Electrodes

Applicant South Dakota Partners

K number K223775

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GXY 2022-12-30

ControlSeal Electrode (ELSB)

Applicant Coapt

K number K223605

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GXY 2022-11-04

Self-adhesive Electrode

Applicant Guangdong Comytens Medical Technology Co., Ltd.

K number K222453

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GXY 2022-09-09

Dexus Prosthetics System (Model: MSL1, MSR1)

Applicant Zhejiang Qiangnao Technology Co.,Ltd

K number K220002

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GXY 2022-05-06

Disposable EEG cable

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K number K213884

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GXY 2022-01-05

Self-adhesive Electrode

Applicant Bozhou Rongjian Medical Appliance Co., Ltd.

K number K213879

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GXY 2021-11-12

Wrap Accessory Electrodes

Applicant Hi-Dow International, Inc.

K number K210383

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GXY 2021-11-09

Comby EEG Caps

Applicant Pamel D.O.O

K number K211315

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GXY 2021-10-06

Adhesive Electrodes

Applicant Voncare Medical Device Co., Ltd.

K number K212191

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GXY 2021-08-31

Adhesive Electrode

Applicant Shaoxing Yingtuo Healthcare Co., Ltd.

K number K210448

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GXY 2021-08-30

Ceribell Instant EEG Headband

Applicant Ceribell, Inc.

K number K210805

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GXY 2021-08-16

Metallic Fabric Electrodes

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K number K202636

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GXY 2021-07-28

Electrode Market Disposable Surface Electrodes

Applicant Electrode Market Co., Ltd.

K number K211839

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GXY 2021-07-08

BioWave BioWraps

Applicant Biowave Corporation

K number K203158

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GXY 2021-06-01

Well-Life Garment Electrodes (GM Series)

Applicant Well-Life Healthcare Limited

K number K200942

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GXY 2021-03-05

NeuroCap (Model DEC22)

Applicant Memory MD, Inc.

K number K202913

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GXY 2021-02-09

MR Conditional Sticky Pad Electrode

Applicant Rhythmlink International, LLC

K number K203079

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GXY 2021-02-03

Jiajian Self-Adhesive Electrode

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K192568

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GXY 2020-06-01

BRAINSTREAM Disposable Deep Cup EEG Electrodes

Applicant Conmed Corporation

K number K200540

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GXY 2020-05-13

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K number K190118

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GXY 2020-04-21

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

Applicant Wuhan Greentek Pty , Ltd.

K number K200162

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GXY 2020-01-21

Disposable Gold Cup EEG Electrodes

Applicant Dymedix Diagnostics, Inc.

K number K192564

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GXY 2019-09-04

Myo Plus

Applicant Otto Bock Healthcare Products GmbH

K number K191179

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GXY 2019-08-05

EEG Electrode Template

Applicant Rhythmlink International, LLC

K number K191225

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GXY 2019-07-02

Wrap accessory electrodes

Applicant Hi-Dow International, Inc.

K number K190617

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GXY 2019-06-14

ELECTRODES PAD

Applicant Shenzhen Bestpad Technology Development Co., Ltd.

K number K190700

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GXY 2019-05-24

COMPLETE CONTROL System Gen2

Applicant Coapt, LLC

K number K191083

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GXY 2019-04-04

Dome Electrode

Applicant Coapt, LLC

K number K190416

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GXY 2019-04-03

DAEHAN Disposable CUP Electrodes

Applicant Daehan Medical Systems Co., Ltd.

K number K180232

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GXY 2019-03-26

SM Electrodes

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K number K183154

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GXY 2019-01-17

DL Self-adhesive Electrode

Applicant Shaoxing DL Healthcare Co., Ltd.

K number K182111

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GXY 2018-11-29

Espire Elbow Pro, Espire Elbow Hybrid

Applicant College Park Industries, Inc.

K number K182757

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GXY 2018-11-01

DAEHAN Adhesive Surface Electrodes

Applicant Daehan Medical Systems Co., Ltd.

K number K180247

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GXY 2018-10-05

Sense System with IBT Electrodes

Applicant Infinite Biomedical Technologies, LLC

K number K182112

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GXY 2018-08-07

Self-adhesive Electrode

Applicant Dong Guan OU Kang Electronics Co., Ltd.

K number K181234

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GXY 2018-06-28

ZMI Self-Adhesive Electrodes

Applicant Zmi Electronics , Ltd.

K number K180865

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GXY 2018-06-01

Silverwear Silver Pro Garment Device

Applicant Media Plus, LLC

K number K171798

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GXY 2018-05-22

Reusable and Self-Adhesive Electrodes

Applicant Shaoxing Dongzhi Electrical Technology Co., Ltd.

K number K180773

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GXY 2018-05-18

EEG-Now

Applicant Encephalodynamics, Inc.

K number K180524

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GXY 2018-04-27

NeuroCap

Applicant Memory MD, Inc.

K number K172866

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GXY 2018-04-19

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K number K172887

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GXY 2018-03-21

Element System with IBT Electrodes

Applicant Infinite Biomedical Technologies, LLC

K number K173571

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GXY 2018-02-28

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D

Applicant Everyway Medical Instruments Co.,Ltd

K number K173186

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GXY 2018-01-10

Electrodes with snap / Electrodes with pigtail

Applicant Shenzhen Konmed Technology Co., Ltd.

K number K171722

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GXY 2018-01-05

Electrodes with silver conductive

Applicant Shenzhen Konmed Technology Co., Ltd.

K number K171721

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GXY 2017-12-21

Ives MR Conditional Cup Electrode

Applicant Ives Egg Solutions

K number K171102

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GXY 2017-12-13

Adhesive Electrodes

Applicant Shenzhen Quality Medical Technology Co.,Ltd

K number K171381

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GXY 2017-12-01

MR Conditional Cup Electrode, MR Conditional Webb Electrode

Applicant Rhythmlink International, LLC

K number K172503

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GXY 2017-11-13

Disposable Snap Electrode

Applicant Embla Systems

K number K172703

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GXY 2017-08-21

Ceribell Instant EEG Headband

Applicant Ceribell, Inc.

K number K171459

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GXY 2017-05-08

Adhesive Electrodes

Applicant Reno Medical , Ltd.

K number K170744

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GXY 2017-04-28

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

Applicant Wavi Co.

K number K162460

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GXY 2017-04-14

Complete Control System

Applicant Coapt, LLC

K number K162891

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GXY 2017-04-11

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96

Applicant Neurovirtual USA, Inc.

K number K163547

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GXY 2016-10-30

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W

Applicant Medico Electrodes International , Ltd.

K number K161282

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GXY 2016-10-19

TENS Electrodes

Applicant Cathay Manufacturing Corp.

K number K160081

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GXY 2016-08-11

Adhesive Electrodes

Applicant Gmdasz Manufacturing Co., Ltd.

K number K160138

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GXY 2016-03-21

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

Applicant Bio Protech, Inc.

K number K153019

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GXY 2016-03-08

Mailuokang Self-adhesive Electrode

Applicant Shenzhen Mailuokang Technology Co., Ltd.

K number K152815

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GXY 2016-02-18

Ennova Self-adhesive Electrode

Applicant Suzhou Ennova Electronics Technology Co.,Ltd

K number K152648

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GXY 2013-12-20

WANDY SELF-ADHESIVE ELECTRODES

Applicant Wandy Rubber Industrial Co., Ltd.

K number K132998

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GXY 2013-11-22

ADHESIVE ELECTRODES

Applicant Top-Rank Health Care Equipment Co., Ltd.

K number K132588

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GXY 2013-07-17

VALUTRODE NEUROSTIMLATION ELECTRODES

Applicant Axelgaard Mfg. Co., Ltd.

K number K130987

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GXY 2013-06-21

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

Applicant Neuro Resource Group, Inc.

K number K130816

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