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510(k) Data Aggregation

    K Number
    K242041
    Device Name
    STOPWET iontophoresis apparatus (SW01)
    Manufacturer
    Taiwan Medical Electronics Co., Ltd.
    Date Cleared
    2025-04-01

    (263 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    Taiwan Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STOPWET is a Tap Water Iontophoresis apparatus. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands and feet.
    Device Description
    STOPWET is designed for individuals suffering from hyperhidrosis (excessive sweating) of the hands and feet. It includes a pulse current generator and two pairs of containers for performing iontophoresis therapy specifically for hyperhidrosis. Users are required to place their hands or feet inside the containers, which contain dampened absorbent pads, and adjust the amplitude of the pulse current to a comfortable level. The circuit for the pulse current is limited to the distal end of the user's hands or feet, thereby minimizing the risk of cardiac discomfort. Additionally, users have the option to treat either the left or right hand using the single-limb treatment mode or treat both hands simultaneously with the dual-limb treatment mode. STOPWET can be used either in a clinical setting or at home. STOPWET is intended for users aged 13 years and above, including teenagers and adults. For teenagers aged 13 to 21 years, it is recommended to use this apparatus under adult supervision.
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