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510(k) Data Aggregation

    K Number
    K071677
    Device Name
    SRT II MUSCLE STIMULATOR
    Date Cleared
    2008-07-11

    (388 days)

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

    THERAPEUTIC INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1 Relaxation of muscle spasms; 2 Prevention or retardation of disuse atrophy; 3 Increasing local blood circulation; 4 Muscle re-education; 5 post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6 Maintaining or increasing range of motion.
    Device Description
    The SRT II Muscle Stimulator is comprised of the following main components: A system console including software and control electronics; A control and display panel: Device accessories including Muscle Stimulator electrodes and cables. The SRT II Device is a 4 mode, 10-channel unit for muscle stimulation housed in a portable case. The microprocessor controlled SRT II Device provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The user friendly interface and its display provides operator information about operation mode and signal intensities.
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