Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
Device Facts
| Record ID | K253237 |
|---|---|
| Device Name | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) |
| Applicant | Elde Medikal Sanayi ve Ticaret Anonim Sirketi |
| Product Code | GXY · Neurology |
| Decision Date | May 8, 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.
