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510(k) Data Aggregation

    K Number
    K981277
    Device Name
    PERIFORM
    Date Cleared
    1998-11-20

    (226 days)

    Product Code
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERIMED HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Biofeedback/monitoring vaginal probe intended for: - Treatment of stress, urge, and mixed incontinence. - Facilitation in identification of the pubococcygeus muscles. - Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.
    Device Description
    The Periform® is a vaginal perineometric probe designed specifically for the acquisition of the naturally present superficial EMG signals of the human vaginal wall. Surface electromyography (sEMG) is the technique of measuring and filtering the electrical impulse (action potential) signals generated by muscle fibers during contraction. The probe conducts these signals to a biofeedback device for further processing. The anatomy of the pelvic floor presents a difficulty in obtaining these signals. The use of a perineometric probe overcomes this difficulty. The purpose of the Periform® is to improve the voluntary control and strength of the pelvic floor muscles with the aid of biofeedback equipment.
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