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510(k) Data Aggregation

    K Number
    K183631
    Device Name
    medi pneumatic compression system (pcs) – brio (Model 651)
    Manufacturer
    Medi USA, LP
    Date Cleared
    2019-01-25

    (30 days)

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

    Medi USA, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The medi pneumatic compression system (pcs) - brio is a compression device based on sequential pneumatic 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) – brio (Model 651) 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 brio (Model 651) 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 with short 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 or 8 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs brio (Model 651) is a basic model and is adjustable and limits the different treatment pressures and treatment times according to physician prescription. The medi pcs brio (Model 651), air hose and 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 sleeves, and all pads that are non-sterile, single patient use. The medi pcs brio (Model 651) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs brio (Model 651)) device, air hoses and air inflatable sleeves together may only be distributed, sold and operated as a prescribed device.
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    K Number
    K051324
    Device Name
    MEDI BUTLER
    Manufacturer
    MEDI USA, LP
    Date Cleared
    2005-12-05

    (199 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI USA, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The medi Bulter is indicated for use as an accessory to medical support stockings. The medi Butler is a lightweight steel frame aid for the application of medical support stockings. The medi Butler is suitable for all compression stocking sizes.
    Device Description
    The Butler is a lightweight steel frame application aid that solves the often difficult problem of applying compression stockings. The application aid is suitable for all compression stocking sizes.
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