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510(k) Data Aggregation

    K Number
    K083704
    Device Name
    NUTRAC PELVATOR, MODEL PEL 200
    Manufacturer
    VERITY SCIENTIFIC LTD.
    Date Cleared
    2009-07-14

    (211 days)

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

    VERITY SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 'NuTracTM Pelvator' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education 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 'NuTrac™ Pelvator' Pelvic Muscle Trainer is a small lightweight battery powered dual channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug.
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