BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    STOPWET iontophoresis apparatus (SW01)

    K Number: K242041 · Decision Apr 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    263

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    Basic Information

    Device Name
    STOPWET iontophoresis apparatus (SW01)
    K Number
    K242041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taiwan Medical Electronics Co., Ltd.
    Date Received
    July 12, 2024
    Decision Date
    April 1, 2025
    Product Code
    EGJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EGJ Device, Iontophoresis, Other Uses

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