Cleared Traditional

STOPWET iontophoresis apparatus (SW01)

K242041 · Taiwan Medical Electronics Co., Ltd. · Physical Medicine

Apr 2025

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K242041 is an FDA 510(k) clearance for the STOPWET iontophoresis apparatus (SW01), a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Taiwan Medical Electronics Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on April 1, 2025, 263 days after receiving the submission on July 12, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number	K242041 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2024
Decision Date	April 01, 2025
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF