K252439
- 510(k) number
- K252439
- Device name
- Tutamen Self Adhesive Electrodes
- Applicant
- Dongguan Tutamen Metalwork Co., Ltd. CN
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-05-01
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252439.pdf
Official FDA record: K252439
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.