Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1320](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1320) → GXY — Electrode, Cutaneous # GXY · Electrode, Cutaneous _Neurology · 21 CFR 882.1320 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY ## Overview - **Product Code:** GXY - **Device Name:** Electrode, Cutaneous - **Regulation:** [21 CFR 882.1320](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1320) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 432) Showing 20 most recent of 432 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260363](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K260363.md) | Ceribell Brain Monitor Headband | Ceribell, Inc. | Apr 3, 2026 | SESE | | [K260453](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K260453.md) | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | Mar 12, 2026 | SESE | | [K254033](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K254033.md) | Ceribell Instant EEG Headset | Ceribell, Inc. | Feb 9, 2026 | SESE | | [K251381](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K251381.md) | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | Oct 31, 2025 | SESE | | [K250841](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K250841.md) | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | Aug 13, 2025 | SESE | | [K243788](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K243788.md) | IceCap product line | Bioserenity Medical Devices Group | Mar 13, 2025 | SESE | | [K243243](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K243243.md) | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | Feb 6, 2025 | SESE | | [K241512](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K241512.md) | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | Jan 15, 2025 | SESE | | [K242326](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K242326.md) | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | Jan 2, 2025 | SESE | | [K241160](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K241160.md) | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | Dec 13, 2024 | SESE | | [K240575](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K240575.md) | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | Nov 25, 2024 | SESE | | [K242346](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K242346.md) | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | Aug 29, 2024 | SESE | | [K240108](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K240108.md) | 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. | Jun 10, 2024 | SESE | | [K240884](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K240884.md) | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | Apr 15, 2024 | SESE | | [K240668](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K240668.md) | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | Mar 19, 2024 | SESE | | [K232995](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K232995.md) | 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. | Jan 11, 2024 | SESE | | [K221199](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K221199.md) | Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Green Island International Tcm Group Limited | Dec 19, 2023 | SESE | | [K231167](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K231167.md) | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. | Aug 9, 2023 | SESE | | [K231164](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K231164.md) | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. | Aug 9, 2023 | SESE | | [K232052](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K232052.md) | Ceribell Instant EEG Headband | Ceribell, Inc. | Aug 8, 2023 | SESE | ## Top Applicants - Empi — 10 clearances - Medtronic Vascular — 10 clearances - Aspect Medical Systems, Inc. — 9 clearances - Labeltape Meditect, Inc. — 9 clearances - Axelgaard Mfg. Co., Ltd. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com