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 437)
Showing 20 most recent of 437 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K261522 | BioWave BioWraps | Biowave Corporation | Jun 3, 2026 | SESE |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | May 8, 2026 | SESE |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | May 7, 2026 | SESE |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | May 1, 2026 | SESE |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | Apr 22, 2026 | SESE |
| 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 |
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
