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510(k) Data Aggregation

    K Number
    K022719
    Device Name
    PHYSICAL MONITORING REGISTRATION UNIT
    Manufacturer
    MARYROSE CUSIMANO, PH.D./PHIL REASTON
    Date Cleared
    2002-11-13

    (90 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARYROSE CUSIMANO, PH.D./PHIL REASTON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities. and refer pain sources. To evaluate a baseline muscle activity for pre-employment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.
    Device Description
    The Physical Monitoring Registration Unit, (PMRU) combines up to 48 channels allowing for a minimum of 18 channels of refined surface EMG to monitor any muscle group in the body. This is also beneficial in monitoring the cardiac muscle. This system also features lead status circuitry to integrate correct placement of all EMG electrodes. The additional channels monitor functional capacity sensors range of motion, the J-Mar grip and pinch strength measurement devices.
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