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510(k) Data Aggregation

    K Number
    K192357
    Device Name
    INNOVO
    Date Cleared
    2020-01-16

    (140 days)

    Product Code
    Regulation Number
    876.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Atlantic Therapeutics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The INNOVO® is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
    Device Description
    The INNOVO® is a powered transcutaneous electrical continence device intended for the treatment of stress urinary incontinence. The device is provided with an internally wired garment which locates eight conductive electrodes around the pelvic area. An electronic controller, which is attached to the garment using a leadwire, delivers an amplitude modulated symmetric biphasic stimulation current to the electrode array to evoke timed muscle contractions in the pelvic floor muscles. A neck strap clips to the unit to allow it to be worn around the neck. The neck strap contains a safety clip which pops open if there is a forceful pull on the neck strap The current amplitude is adjusted by the patient using a push-button intensity control. A treatment lasts for 30 minutes and is self-administered by the patient at home. The electronic controller operates from rechargeable batteries and a mechanical interlock is provided to prevent simultaneous connection to the patient and the charger. The INNOVO® is supplied with a non-sterile, electrically conductive, electrolyte spray.
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