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510(k) Data Aggregation

    K Number
    K221654
    Device Name
    medi pneumatic compression system (pcs)-genius (Model 652)
    Manufacturer
    Date Cleared
    2022-07-07

    (30 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    medi USA, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The medi pneumatic compression system (pcs) genius is a compression device based on sequential neumatic compression technique which is intended for the treatment of the following conditions: -Lymphedema -Venous stasis ulcers -Venous insufficiency -Peripheral edema The device is intended for home, and hospital use.
    Device Description
    The medi pneumatic compression system (pcs) genius (Model 652) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use. The medi pcs genius (Model 652) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable sleeves with air hose and connectors, a power switch, and a wall power connection for standard 125v AC Power. The PCU provides compression in cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6, 8, or 10 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs genius (Model 652) is adjustable and limits the different treatment pressures and treatment times according to clinician prescription. The medi pcs genius (Model 652) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs genius (Model 652) device, air hoses and air inflatable sleeves together may only be distributed, sold, and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeve(s) that are non-sterile and single patient use.
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