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510(k) Data Aggregation

    K Number
    K242922
    Device Name
    Extracorporeal Shock Wave Lithotripter (U200)
    Manufacturer
    Shenzhen Wikkon Precision Technologies Co., Ltd.
    Date Cleared
    2025-06-18

    (267 days)

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

    Shenzhen Wikkon Precision Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
    Device Description
    The Extracorporeal Shock Wave Lithotripter, U200, is intended to treat urinary tract stones using ESWL. The Extracorporeal Shock Wave Lithotripter generates high-energy shock waves using a shock wave generator that is focused to produce a highly concentrated stress area at the focal point. These pressure pulses are focused on a specific point in the body where the Urinary calculi are located using assisted movement and manual localization through B-ultrasound. The pressure generated by the shock wave causes the human urinary tract stones to produce physical effects to achieve the therapeutic purpose of crushing stones. The Extracorporeal Shock Wave Lithotripter, U200, is composed of main unit, control console, patient table, electrical cabinet, power supply unit, and computer. Control platform is integrated control of electric cabinet, main engine and treatment bed. Electrical cabinet is used to provide power control of the whole machine, and shock wave source function control. Main Unit contains the L-shape arm and the support matrix of the impact wave source, and realize the movement of L-shape arm up and down, rotation and oscillation of the impact wave source inside and outside. Power box is power supply of the whole machine, power supply input voltage 120 V, 60 Hz, 3000VA. Treatment bed is used for patient support and treatment position, and provides three-dimensional movement to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling. Principle of operation: The extracorporeal shock wave lithotripter generates pressure pulses using an electromagnetic shock wave generator, with water serving as the transmission medium. These high energy shock waves with peak acoustic pressure up to 35MPa are focused on a specific point using a lens. In addition, the lithotripter often incorporates an ultrasound-based assisted movement system which locates and aligns the shock wave focus with the urinary tract stone. The shock waves create a stress effect on the stone. After several hundred to around two thousand discharges, the stones are fragmented into smaller pieces which can be excreted from the body.
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