GXY · Electrode, Cutaneous
Neurology · 21 CFR 882.1320 · Class 2
Overview
| Product Code | GXY |
|---|---|
| Device Name | Electrode, Cutaneous |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Ceribell Brain Monitor Headband | Ceribell, Inc. | Apr 3, 2026 | SESE |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | Mar 12, 2026 | SESE |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | Feb 9, 2026 | SESE |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | Oct 31, 2025 | SESE |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | Aug 13, 2025 | SESE |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | Mar 13, 2025 | SESE |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | Feb 6, 2025 | SESE |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | Jan 15, 2025 | SESE |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | Jan 2, 2025 | SESE |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | Dec 13, 2024 | SESE |
| K240575 | 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 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | Aug 29, 2024 | SESE |
| 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. | Jun 10, 2024 | SESE |
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | Apr 15, 2024 | SESE |
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | Mar 19, 2024 | SESE |
| 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. | Jan 11, 2024 | SESE |
| K221199 | Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Green Island International Tcm Group Limited | Dec 19, 2023 | SESE |
| K231167 | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. | Aug 9, 2023 | SESE |
| K231164 | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. | Aug 9, 2023 | SESE |
| K232052 | 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
