BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ATHENA PELVIC MUSCLE TRAINER II

    K Number: K033256 · Decision Dec 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    ATHENA PELVIC MUSCLE TRAINER II
    K Number
    K033256
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Athena Feminine Technologies, Inc.
    Date Received
    October 9, 2003
    Decision Date
    December 30, 2003
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Athena Feminine Technologies, Inc.

    K Number Device Name
    K023905 ATHENA PELVIC MUSCLE TRAINER