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FDA 510(k)

STOPWET iontophoresis apparatus (SW01)

K-Number: K242041 · 2025-04-01

ApplicantTaiwan Medical Electronics Co., Ltd.
Decision Date2025-04-01
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STOPWET iontophoresis apparatus (SW01) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K242041. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOPWET iontophoresis apparatus (SW01)?

STOPWET iontophoresis apparatus (SW01) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Taiwan Medical Electronics Co., Ltd.. The 510(k) number is K242041.

When did STOPWET iontophoresis apparatus (SW01) receive FDA 510(k) clearance?

STOPWET iontophoresis apparatus (SW01) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K242041.

Who is the listed applicant for STOPWET iontophoresis apparatus (SW01)?

The FDA 510(k) record lists Taiwan Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STOPWET iontophoresis apparatus (SW01)?

The FDA product code for STOPWET iontophoresis apparatus (SW01) is EGJ.

Related Devices (Code: EGJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241267Hidroxa SE30Hidroxa Medical ABK232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KGK170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech DevelopmentK170291IontoDCSoterix Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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