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510(k) Data Aggregation

    K Number
    K123902
    Device Name
    PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
    Manufacturer
    OKTX LLC
    Date Cleared
    2013-09-13

    (269 days)

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

    OKTX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surface Electromyography with range of motion functional capacity assessment grip and pinch strength. The Intended Use Section is identical to the original device PMRU (K022719) 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 preemployment 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-S, (PMRU-S) like the legally cleared PMRU combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors. This integration allows for a reproducible, objective interpretation of muscle function and effort via the range of motion, fce, pinch and grip. All muscle groups of the body from cervical (to mid back, low back and extremities can be monitored with the device). Bilateral muscle testing is done to compare antagonist muscle groups. The devices monitors bilateral muscle activity with the force produced by the patient while he or she pulls on the strain gauge, with the range of motion. is to provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To measure surface emg along the spine, extremities or cervical region. To measure the EMG with functional tasks, to measure the EMG with range of motion, to measure the EMG with pinch and or grip. This this is identical to the already cleared PMRU.
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