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510(k) Data Aggregation

    K Number
    K171896
    Device Name
    Feminine Personal Trainer (FPT)
    Manufacturer
    Ralston Group
    Date Cleared
    2017-08-29

    (64 days)

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

    Ralston Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
    Device Description
    The FPT is designed specifically for women for their use in strengthening the pelvic floor musculature. It is a single, reusable, home-use device that comes into contact with the vaginal mucosal membrane for a limited (< 24 hours) duration per each use. The FPT is an hourglass-shaped device made from surgical stainless steel. The FPT is available in three sizes: standard, small and petite. The FPT is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The hourglass shape ensures automatic positioning so that the appropriate muscles are targeted. The weight of the FPT provides resistance as it is gently lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.
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