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510(k) Data Aggregation

    K Number
    K121902
    Device Name
    NATRATONE
    Manufacturer
    ORELLE CORPORATION LTD
    Date Cleared
    2013-06-06

    (342 days)

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

    ORELLE CORPORATION LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NatraTone® 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
    NatraTone® is a pelvic floor muscle exerciser. It is a single, reusable device that comes into contact with the vaginal mucosal membrane for a limited (<24 hours) duration per each use. The device is 3.25 inches in length, 1.35 inch in width at its buibous base end and weighs 1 once or 28 grams. The registered trade name 'NatraTone' is embedded in the thumb-hold area of the device. The device is fully inserted to sit low in the vagina in contact with the perineal muscles.
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