FDA Product Code
FDA Product Code GXY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1320
510(k) Clearances — 440 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | 2026-08-27 | Special | PDF ↗ |
| K260578 | 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) | Ambu A/S | 2026-07-14 | Traditional | PDF ↗ |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | 2026-06-26 | Abbreviated | PDF ↗ |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 | Special | PDF ↗ |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 | Traditional | PDF ↗ |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026-05-07 | Traditional | PDF ↗ |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 | Traditional | PDF ↗ |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | 2026-04-22 | Traditional | PDF ↗ |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026-04-03 | Abbreviated | PDF ↗ |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | 2026-03-12 | Special | PDF ↗ |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026-02-09 | Abbreviated | PDF ↗ |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | 2025-10-31 | Abbreviated | PDF ↗ |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | 2025-08-13 | Traditional | PDF ↗ |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025-03-13 | Traditional | PDF ↗ |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | 2025-02-06 | Traditional | PDF ↗ |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 | Traditional | PDF ↗ |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025-01-02 | Traditional | PDF ↗ |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | 2024-12-13 | Traditional | PDF ↗ |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | 2024-11-25 | Traditional | PDF ↗ |
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | 2024-08-29 | Traditional | PDF ↗ |
| K240108 | 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) | Gymmax Technology Shenzhen Co., Ltd. | 2024-06-10 | Traditional | PDF ↗ |
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | 2024-04-15 | Traditional | PDF ↗ |
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024-03-19 | Traditional | PDF ↗ |
| K232995 | 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 | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-11 | Traditional | PDF ↗ |
| K221199 | Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Green Island International Tcm Group Limited | 2023-12-19 | Traditional | PDF ↗ |
| K231167 | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 | Traditional | PDF ↗ |
| K231164 | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 | Traditional | PDF ↗ |
| K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023-08-08 | Special | PDF ↗ |
| K221589 | Starly pad | Shenzhen Xingyuanli Technology Co., Ltd. | 2023-03-24 | Traditional | PDF ↗ |
| K230533 | Motive Electrode | Cymedica Orthopedics, Inc. | 2023-03-22 | Traditional | PDF ↗ |
| K223086 | Ceribell Instant EEG Headcap | Ceribell, Inc. | 2023-03-22 | Abbreviated | PDF ↗ |
| K222671 | DeltaScan Patch | Prolira B.V. | 2023-02-02 | Traditional | PDF ↗ |
| K222863 | Garment Electrodes | Tone-A-Matic International, Inc. | 2023-02-01 | Traditional | PDF ↗ |
| K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023-01-19 | Traditional | PDF ↗ |
| K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-01-19 | Traditional | PDF ↗ |
| K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023-01-11 | Special | PDF ↗ |
| K223775 | EZ-STIK Electrodes | South Dakota Partners | 2023-01-03 | Traditional | PDF ↗ |
| K223605 | ControlSeal Electrode (ELSB) | Coapt | 2022-12-30 | Special | PDF ↗ |
| K222453 | Self-adhesive Electrode | Guangdong Comytens Medical Technology Co., Ltd. | 2022-11-04 | Traditional | PDF ↗ |
| K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | 2022-09-09 | Traditional | PDF ↗ |
| K213884 | Disposable EEG cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2022-05-06 | Abbreviated | PDF ↗ |
| K213879 | Self-adhesive Electrode | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-01-05 | Traditional | PDF ↗ |
| K210383 | Wrap Accessory Electrodes | Hi-Dow International, Inc. | 2021-11-12 | Traditional | PDF ↗ |
| K211315 | Comby EEG Caps | Pamel D.O.O | 2021-11-09 | Traditional | PDF ↗ |
| K212191 | Adhesive Electrodes | Voncare Medical Device Co., Ltd. | 2021-10-06 | Traditional | PDF ↗ |
| K210448 | Adhesive Electrode | Shaoxing Yingtuo Healthcare Co., Ltd. | 2021-08-31 | Traditional | PDF ↗ |
| K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021-08-30 | Traditional | PDF ↗ |
| K202636 | Metallic Fabric Electrodes | Guangzhou Xinbo Electronic Co., Ltd. | 2021-08-16 | Traditional | PDF ↗ |
| K211839 | Electrode Market Disposable Surface Electrodes | Electrode Market Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K203158 | BioWave BioWraps | Biowave Corporation | 2021-07-08 | Traditional | PDF ↗ |
| K200942 | Well-Life Garment Electrodes (GM Series) | Well-Life Healthcare Limited | 2021-06-01 | Traditional | PDF ↗ |
| K202913 | NeuroCap (Model DEC22) | Memory MD, Inc. | 2021-03-05 | Traditional | PDF ↗ |
| K203079 | MR Conditional Sticky Pad Electrode | Rhythmlink International, LLC | 2021-02-09 | Traditional | PDF ↗ |
| K192568 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-02-03 | Special | PDF ↗ |
| K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | Conmed Corporation | 2020-06-01 | Traditional | PDF ↗ |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | Guangzhou Xinbo Electronic Co., Ltd. | 2020-05-13 | Traditional | PDF ↗ |
| K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty , Ltd. | 2020-04-21 | Abbreviated | PDF ↗ |
| K192564 | Disposable Gold Cup EEG Electrodes | Dymedix Diagnostics, Inc. | 2020-01-21 | Traditional | PDF ↗ |
| K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | 2019-09-04 | Traditional | PDF ↗ |
| K191225 | EEG Electrode Template | Rhythmlink International, LLC | 2019-08-05 | Traditional | PDF ↗ |
| K190617 | Wrap accessory electrodes | Hi-Dow International, Inc. | 2019-07-02 | Traditional | PDF ↗ |
| K190700 | ELECTRODES PAD | Shenzhen Bestpad Technology Development Co., Ltd. | 2019-06-14 | Traditional | PDF ↗ |
| K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019-05-24 | Special | PDF ↗ |
| K190416 | Dome Electrode | Coapt, LLC | 2019-04-04 | Abbreviated | PDF ↗ |
| K180232 | DAEHAN Disposable CUP Electrodes | Daehan Medical Systems Co., Ltd. | 2019-04-03 | Traditional | PDF ↗ |
| K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-03-26 | Traditional | PDF ↗ |
| K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019-01-17 | Traditional | PDF ↗ |
| K182757 | Espire Elbow Pro, Espire Elbow Hybrid | College Park Industries, Inc. | 2018-11-29 | Traditional | PDF ↗ |
| K180247 | DAEHAN Adhesive Surface Electrodes | Daehan Medical Systems Co., Ltd. | 2018-11-01 | Traditional | PDF ↗ |
| K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018-10-05 | Traditional | PDF ↗ |
| K181234 | Self-adhesive Electrode | Dong Guan OU Kang Electronics Co., Ltd. | 2018-08-07 | Traditional | PDF ↗ |
| K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics , Ltd. | 2018-06-28 | Traditional | PDF ↗ |
| K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | 2018-06-01 | Traditional | PDF ↗ |
| K180773 | Reusable and Self-Adhesive Electrodes | Shaoxing Dongzhi Electrical Technology Co., Ltd. | 2018-05-22 | Traditional | PDF ↗ |
| K180524 | EEG-Now | Encephalodynamics, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K172866 | NeuroCap | Memory MD, Inc. | 2018-04-27 | Traditional | PDF ↗ |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) | Guangzhou Xinbo Electronic Co., Ltd. | 2018-04-19 | Traditional | PDF ↗ |
| K173571 | Element System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018-03-21 | Traditional | PDF ↗ |
| K173186 | S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D | Everyway Medical Instruments Co.,Ltd | 2018-02-28 | Special | PDF ↗ |
| K171722 | Electrodes with snap / Electrodes with pigtail | Shenzhen Konmed Technology Co., Ltd. | 2018-01-10 | Traditional | PDF ↗ |
| K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | 2018-01-05 | Traditional | PDF ↗ |
| K171102 | Ives MR Conditional Cup Electrode | Ives Egg Solutions | 2017-12-21 | Traditional | PDF ↗ |
| K171381 | Adhesive Electrodes | Shenzhen Quality Medical Technology Co.,Ltd | 2017-12-13 | Traditional | PDF ↗ |
| K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2017-12-01 | Traditional | PDF ↗ |
| K172703 | Disposable Snap Electrode | Embla Systems | 2017-11-13 | Abbreviated | PDF ↗ |
| K171459 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2017-08-21 | Traditional | PDF ↗ |
| K170744 | Adhesive Electrodes | Reno Medical , Ltd. | 2017-05-08 | Traditional | PDF ↗ |
| K162460 | WAVi Headset and WAVi eSoc Single Use Electrode Contacts | Wavi Co. | 2017-04-28 | Traditional | PDF ↗ |
| K162891 | Complete Control System | Coapt, LLC | 2017-04-14 | Traditional | PDF ↗ |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Neurovirtual USA, Inc. | 2017-04-11 | Traditional | PDF ↗ |
| K161282 | FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W | Medico Electrodes International , Ltd. | 2016-10-30 | Traditional | PDF ↗ |
| K160081 | TENS Electrodes | Cathay Manufacturing Corp. | 2016-10-19 | Traditional | PDF ↗ |
| K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016-08-11 | Traditional | PDF ↗ |
| K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes | Bio Protech, Inc. | 2016-03-21 | Traditional | PDF ↗ |
| K152815 | Mailuokang Self-adhesive Electrode | Shenzhen Mailuokang Technology Co., Ltd. | 2016-03-08 | Traditional | PDF ↗ |
| K152648 | Ennova Self-adhesive Electrode | Suzhou Ennova Electronics Technology Co.,Ltd | 2016-02-18 | Traditional | PDF ↗ |
| K151693 | Dr-Ho's Foot Pad Electrode | Drtv Asia, Ltd. | 2015-10-09 | Traditional | PDF ↗ |
| K151576 | Neon EEG | Incereb, Ltd. | 2015-09-29 | Traditional | PDF ↗ |
| K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015-08-25 | Traditional | PDF ↗ |
| K151033 | Philips Self-Adhesive Electrodes | Philips Consumer Lifestyle | 2015-07-28 | Traditional | PDF ↗ |
Product code GXY · Class II · Neurology. Data: openFDA.