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    K Number
    K152115
    Device Name
    Renew NCP-5 External Counterpulsation System
    Manufacturer
    Stage 2 Innovations
    Date Cleared
    2015-12-17

    (141 days)

    Product Code
    DRN
    Regulation Number
    870.5225
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    Applicant Name (Manufacturer) :

    Stage 2 Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Renew NCP-5 External Counterpulsation System is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
    Device Description
    The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.
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