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510(k) Data Aggregation

    K Number
    K201257
    Device Name
    MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
    Manufacturer
    Date Cleared
    2021-04-06

    (330 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arrive Systems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology. It is intended to be used on healthy muscles and clients, not for rehabilitation purposes. MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. MI.BO. ® MyoBoost EMS System (MB-1000, MB-400) training programs are NOT designed for injured or ailing muscles and its use on such muscles is contraindicated. The various types of muscle work that the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) can impose on the stimulated muscles are able to improve or facilitate muscle performance.
    Device Description
    MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology.
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