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510(k) Data Aggregation

    K Number
    K033256
    Device Name
    ATHENA PELVIC MUSCLE TRAINER II
    Manufacturer
    ATHENA FEMININE TECHNOLOGIES, INC.
    Date Cleared
    2003-12-30

    (82 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATHENA FEMININE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
    Device Description
    The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operale one in escripted Description of the Device. The Atlena Perio Missic Trans 15 a raginal vide of the remote control and is activated upon removal from the cradle.
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    K Number
    K023905
    Device Name
    ATHENA PELVIC MUSCLE TRAINER
    Manufacturer
    ATHENA FEMININE TECHNOLOGIES, INC.
    Date Cleared
    2003-04-30

    (159 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATHENA FEMININE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
    Device Description
    The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operated through a FM remote control device. The probe is stored in an activator box that turns the probe on automatically when the probe is removed from the box.
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