Tutamen Self Adhesive Electrodes
Device Facts
| Record ID | K252439 |
|---|---|
| Device Name | Tutamen Self Adhesive Electrodes |
| Applicant | Dongguan Tutamen Metalwork Co., Ltd. |
| Product Code | GXY · Neurology |
| Decision Date | May 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
Regulatory Classification
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.
