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510(k) Data Aggregation

    K Number
    K101482
    Device Name
    EM-9000
    Manufacturer
    Date Cleared
    2011-03-31

    (307 days)

    Product Code
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELITE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
    Device Description
    The EM-9000 consists of: (1) a Therapy Unit; and (2) a Control Interface Master. The Therapy Unit consists of the following sub-modules: (a) shock wave generator with therapy head; (b) patient table (c) optional Ultrasound Localization System ("ULS"); and (d) accessories. The Electronics Module is mounted within the EM-9000's Housing. Since all of the assembly parts are collected on the main body of the unit, it is a self-contained unit for providing the lithotripsy application. The Control Interface Master consists of the following sub-modules: Hand Held Remote Control Box, Hand Held Table Control Box and Foot Pedal (Optional) The shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an electromagnetic coil, a membrane, an acoustical lens for focusing and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient. The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit.
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