Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021115
    Device Name
    GYNEFLEX
    Manufacturer
    NAISSANCE HOLDINGS, LC
    Date Cleared
    2002-12-20

    (256 days)

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

    NAISSANCE HOLDINGS, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GyneFlex is recommended for the strengthening of the perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence.
    Device Description
    The GyneFlex is a pelvic floor muscle exerciser. The product has six ranges of resistance. Other than variation in resistance, each exerciser is identical, including identical indications and labeling. It is a "v" sh aped device that provides resistance after insertion into the vagina when the patient contracts her pelvic muscles. The material is made of a polymer plastic specifically formulated to provide specific ranges of resistance for use as an adjunct to Kegel exercises.
    Ask a Question

    Page 1 of 1