Cleared Traditional

K242041 - STOPWET iontophoresis apparatus (SW01)

K242041 is an FDA 510(k) clearance for STOPWET iontophoresis apparatus (SW01), manufactured by Taiwan Medical Electronics Co., Ltd.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K242041 · Taiwan Medical Electronics Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
263d
Days
Class 2
Risk

K242041 is an FDA 510(k) clearance for the STOPWET iontophoresis apparatus (SW01). Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Taiwan Medical Electronics Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on April 1, 2025 after a review of 263 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Taiwan Medical Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K242041

510(k) Number K242041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 115d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 30
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K242041.
Hidroxa SE30
K241267 · Hidroxa Medical AB · Oct 2024
Iontophoresis Electrodes
K232020 · Top-Rank Health Care Co., Ltd. · Oct 2023
Dermadry
K192749 · Dermadry Laboratories, Inc. · Feb 2020
Saalio
K191436 · Saalmann Medical GmbH & Co. KG · Oct 2019
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835 · Hightech Development · Jun 2018
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015