Tutamen Self Adhesive Electrodes— 510(k) K252439

Name: FDA 510(k) clearance K252439
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Substantially Equivalent

Dongguan Tutamen Metalwork Co., Ltd.

FDA 510(k) clearance K252439 for Tutamen Self Adhesive Electrodes, Substantially Equivalent on 2026-05-01. Applicant: Dongguan Tutamen Metalwork Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dongguan Tutamen Metalwork Co., Ltd.
Product code: Code GXY
Device class: Class 2
Regulation: 21 CFR 882.1320
Advisory panel: Neurology
Date received: 2025-08-04
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

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