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510(k) Data Aggregation

    K Number
    K071040
    Device Name
    WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
    Date Cleared
    2007-05-22

    (40 days)

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

    WRIGHT LINEAR PUMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wright 51 and 52 Sequential Compression System is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
    Device Description
    The Wright 51 and 52 Sequential Compression System consists of a sequential, segmental, intermittent, pneumatic compression pump and appropriate limb appliances. It is typically used to compress an upper or lower body extremity. The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential opening and closing of the solenoid valves, which are connected to five (5) external pressure ports. The pressure ports are connected to the limb appliance through a hose assembly. The inflatable limb appliance is made of fabric and may comprise from one to five cells, with the length of the appliance dependent upon the physician's order or patients limb length. In operation, the pump fills the inflatable limb appliance with air, to prescribed, preset pressures -- each cell in sequence. This simple repetition of the sequence of compression and exhaust improves return blood circulation for the patient.
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    K Number
    K961292
    Device Name
    WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
    Date Cleared
    1996-11-06

    (216 days)

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

    WRIGHT LINEAR PUMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
    Device Description
    This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.
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    K Number
    K961797
    Device Name
    WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
    Date Cleared
    1996-11-06

    (181 days)

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

    WRIGHT LINEAR PUMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders. Complies with physician-prescribed treatment pressures.
    Device Description
    This is an electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages to sequentially inflate a sleeve appliance that fits over the patient's extremity. This unit delivers a calibrated gradient pressure. The device is approximately 10"W x 6.75"H x 5.6"D and weighs less than 15 Ibs.
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    K Number
    K961891
    Device Name
    WLP SINGLE-SEGMENT VERSION WLP SOLO VII
    Date Cleared
    1996-11-06

    (181 days)

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

    WRIGHT LINEAR PUMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
    Device Description
    This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 Ibs.
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