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    K Number
    K011688
    Device Name
    PELVICFLEXER EXERCISE DEVICE
    Manufacturer
    PELVICFLEX, INC.
    Date Cleared
    2002-03-20

    (293 days)

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

    PELVICFLEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PelvicFlexer is intended to assist women in performing Kegel Exercises which may help control stress urinary incontinence. Treatment of stress and /or Urge incontinence in women
    Device Description
    The PelvicFlexer is a comprehensive, behaviorally based program designed for independent use by incontinence people at home. The program includes a PelvicFlexer device, instructional manual and direct support via phone and internet. The PelvicFlexer is hand-held and inserted into the vagina. The strength of the muscle contraction is reflected by the stainless steel springs.
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