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510(k) Data Aggregation

    K Number
    K160378
    Device Name
    BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
    Manufacturer
    BRH Medical Ltd.
    Date Cleared
    2017-08-25

    (562 days)

    Product Code
    IMI, GZJ, IPF, LIH
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRH Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therapeutic Ultrasound: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation: 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increase of blood flow in the treatment area. 5. Prevention or retardation of disuse atrophy in post-injury type conditions 6. Muscle re-education 7. Maintaining or increasing range of motion
    Device Description
    The BRH-A2 CUSEFS is comprised of the following main components: - A system console including software and control electrodes; ● - A control and display panel - Specially designed cart - User-friendly touch screen . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply. The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes. There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation. The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.
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