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

Company510(k)sRecalls
Empi100
Medtronic Vascular100
Aspect Medical Systems, Inc.90
Labeltape Meditect, Inc.90
Axelgaard Mfg. Co., Ltd.80
Chalgren Enterprises, Inc.80
Cadwell Laboratories, Inc.70
Ceribell, Inc.70
Coapt52
Medical Devices, Inc.70
Decided510(k)Device and applicantCode
Oct 20, 2026K262664Rongjian Self-adhesive Electrode
Bozhou Rongjian Medical Appliance Co., Ltd., CN
GXY
Aug 27, 2026K262654Dexus Prosthetic System (MSL2, MSR2)
Zhejiang Qiangnao Technology Co.,Ltd, CN
GXY
Jul 14, 2026K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set
Ambu A/S, DK
GXY
Jun 26, 2026K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
Cadwell Industries, Inc.
GXY
Jun 3, 2026K261522BioWave BioWraps
Biowave Corporation
GXY
May 8, 2026K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
Elde Medikal Sanayi ve Ticaret Anonim Sirketi, TR
GXY
May 7, 2026K254183MR Conditional Cup Electrodes
Technomed Europe, NL
GXY
May 1, 2026K252439Tutamen Self Adhesive Electrodes
Dongguan Tutamen Metalwork Co., Ltd., CN
GXY
Apr 22, 2026K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
Otto Bock Healthcare Products GmbH, AT
GXY
Apr 3, 2026K260363Ceribell Brain Monitor Headband
Ceribell, Inc.
GXY
Mar 12, 2026K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
Bionit Labs Srl, IT
GXY
Feb 9, 2026K254033Ceribell Instant EEG Headset
Ceribell, Inc.
GXY
Oct 31, 2025K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
Ceribell, Inc.
GXY
Aug 13, 2025K250841Electrotherapy Electrodes
Baisheng Medical Co., Ltd., CN
GXY
Mar 13, 2025K243788IceCap product line
Bioserenity Medical Devices Group, FR
GXY
Feb 6, 2025K243243Delphi MCS Electrode Cap
Quantalx Neuroscience, Ltd., IL
GXY
Jan 15, 2025K241512Electrode Pad
Shenzhen Deliduo Medical Technology Co.,Ltd, CN
GXY
Jan 2, 2025K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)
Bionit Labs Srl, IT
GXY
Dec 13, 2024K241160CAIs Sensor (CAIs-001)
Brainu Co., Ltd., KR
GXY
Nov 25, 2024K240575WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
Eemagine Medical Imaging Solutions GmbH, DE
GXY
Aug 29, 2024K242346Grass® MR Conditional/CT Cup Electrodes
Natus Manufacturing Limited, IE
GXY
Jun 10, 2024K240108Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; G
Gymmax Technology Shenzhen Co., Ltd., CN
GXY
Apr 15, 2024K240884Glide (91000-GL-X)
Infinite Biomedical Technologies, LLC
GXY
Mar 19, 2024K240668Amydi-med Disposable Non-invasive EEG electrodes
Shenzhen Amydi-Med Electrics Tech Co., Ltd., CN
GXY
Jan 11, 2024K232995Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC
Shenzhen Roundwhale Technology Co. , Ltd., CN
GXY
Dec 19, 2023K221199Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
Green Island International Tcm Group Limited, CN
GXY
Aug 9, 2023K231167Conductive Silicone Rubber Electrode
Guangzhou Xinbo Electronic Co., Ltd., CN
GXY
Aug 9, 2023K231164Conductive carbon film electrode
Guangzhou Xinbo Electronic Co., Ltd., CN
GXY
Aug 8, 2023K232052Ceribell Instant EEG Headband
Ceribell, Inc.
GXY
Mar 24, 2023K221589Starly pad
Shenzhen Xingyuanli Technology Co., Ltd., CN
GXY
Mar 22, 2023K230533Motive™ Electrode
Cymedica Orthopedics, Inc.
GXY
Mar 22, 2023K223086Ceribell Instant EEG Headcap
Ceribell, Inc.
GXY
Feb 2, 2023K222671DeltaScan Patch
Prolira B.V., NL
GXY
Feb 1, 2023K222863Garment Electrodes
Tone-A-Matic International, Inc., CA
GXY
Jan 19, 2023K222252Self-adhesive Electrode
Shenzhen Roundwhale Technology Co. , Ltd., CN
GXY
Jan 19, 2023K220448Disposable Non-invasive EEG Sensor
Shenzhen Med-Link Electronics Tech Co., Ltd., CN
GXY
Jan 11, 2023K223738Alpha Control Liner System (ACLS)
Coapt
GXY
Jan 3, 2023K223775EZ-STIK Electrodes
South Dakota Partners
GXY
Dec 30, 2022K223605ControlSeal Electrode (ELSB)
Coapt
GXY
Nov 4, 2022K222453Self-adhesive Electrode
Guangdong Comytens Medical Technology Co., Ltd., CN
GXY
Sep 9, 2022K220002Dexus Prosthetics System (Model: MSL1, MSR1)
Zhejiang Qiangnao Technology Co.,Ltd, CN
GXY
May 6, 2022K213884Disposable EEG cable
Shenzhen Changke Connect Electronics Co., Ltd., CN
GXY
Jan 5, 2022K213879Self-adhesive Electrode
Bozhou Rongjian Medical Appliance Co., Ltd., CN
GXY
Nov 12, 2021K210383Wrap Accessory Electrodes
Hi-Dow International, Inc.
GXY
Nov 9, 2021K211315Comby EEG Caps
Pamel D.O.O, HR
GXY
Oct 6, 2021K212191Adhesive Electrodes
Voncare Medical Device Co., Ltd., CN
GXY
Aug 31, 2021K210448Adhesive Electrode
Shaoxing Yingtuo Healthcare Co., Ltd., CN
GXY
Aug 30, 2021K210805Ceribell Instant EEG Headband
Ceribell, Inc.
GXY
Aug 16, 2021K202636Metallic Fabric Electrodes
Guangzhou Xinbo Electronic Co., Ltd., CN
GXY
Jul 28, 2021K211839Electrode Market Disposable Surface Electrodes
Electrode Market Co., Ltd., KR
GXY

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