STOPWET iontophoresis apparatus (SW01)— 510(k) K242041

Name: FDA 510(k) clearance K242041
Creator: U.S. Food and Drug Administration
Published: 2025-04-01

Substantially Equivalent

Taiwan Medical Electronics Co., Ltd.

FDA 510(k) clearance K242041 for STOPWET iontophoresis apparatus (SW01), Substantially Equivalent on 2025-04-01. Applicant: Taiwan Medical Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Taiwan Medical Electronics Co., Ltd.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2024-07-12
Decision date: 2025-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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