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510(k) Data Aggregation

    K Number
    K131046
    Device Name
    VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
    Date Cleared
    2013-07-18

    (94 days)

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

    VENOUS HEALTH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the lower limb(s) in the clinical setting or home environment. The Vasculaire Compression System is indicated for use in: - Preventing deep vein thrombosis (DVT) - Enhancing blood circulation - Diminishing post-operative pain and swelling - Reducing wound healing time - Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers - Treatment of chronic venous insufficiency - Reducing edema
    Device Description
    The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide compression therapy to the lower limb(s) in the clinical setting or home environment. The Vasculaire Compression System includes three components: the Controller, the Sleeve and the Charger. The Sleeve is a multiple-cell bladder intended to be attached directly to the lower limb(s). It is intended to provide compression to the tissue surrounding the vasculature. The Sleeve is provided in two configurations. The first configuration is a foot and calf Sleeve that provides sequential compression to the foot and calf. The second configuration is a calf only Sleeve that provides sequential compression to the calf. The Controller is connected to the Sleeve using two flange ports and can be mounted directly onto the Sleeve for a fully mobile system. The flange ports allow the air from the Controller to effect compression on the foot and calf zones independently. The Controller allows the user to select between foot and calf compression or a calf only compression. The Controller also allows the user to select compression cycles of approximately one to three cycles per minute. The Controller is a lightweight (less than 1 lb.), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy. The Charger consists of a medical grade power supply and the table top docking station.
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    K Number
    K122609
    Device Name
    VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
    Date Cleared
    2012-12-21

    (116 days)

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

    VENOUS HEALTH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vasculaire Compression System is indicated for use in: - Preventing deep vein thrombosis (DVT) - Enhancing blood circulation - Diminishing post-operative pain and swelling - Reducing wound healing time - Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers - Treatment of chronic venous insufficiency - Reducing edema
    Device Description
    The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the patient's lower limb(s). The Controller is battery powered, provides selectable compression cycles and system monitoring of the compression therapy. The Sleeves are provided in a foot & calf or a calf only configuration for selectable lower limb(s) compression therapy. The Vasculaire Compression System includes three components: the Controller, the Sleeve and the Charger. The Sleeve is a multiple-cell bladder intended to be attached directly to the lower limb(s). It is intended to provide compression to the tissue surrounding the vasculature. The Sleeve is provided in two configurations. The first configuration is a foot and calf Sleeve that provides sequential compression to the foot and calf. The second configuration is a calf only Sleeve that provides sequential compression to the calf. The Controller is connected to the Sleeve using two flange ports and can be mounted directly onto the Sleeve for a fully mobile system. The flange ports allow the air from the Controller to effect compression on the foot and calf zones independently. The Controller allows the user to select between foot and calf compression or a calf only compression. The Controller also allows the user to select compression cycles of approximately one to three cycles per minute. The Controller is a lightweight (less than 1 Ib.), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy. The Charger consists of a medical grade power supply and the table top docking station.
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    K Number
    K103113
    Device Name
    VASCULAIRE COMPRESSION SYSTEM
    Date Cleared
    2011-02-02

    (104 days)

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

    VENOUS HEALTH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vasculaire Compression System is indicated for use in: - Preventing deep vein thrombosis (DVT) . - . Enhancing blood circulation - Diminishing post-operative pain and swelling . - t Reducing wound healing time - Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial . and diabetic leg ulcers - Treatment of chronic venous insufficiency . - . Reducing edema
    Device Description
    The Vasculaire Compression System is an ambulatory, intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The Vasculaire Compression System includes three components: the Patient Sleeve, the Controller, and the Charger. The Patient Sleeve is a multiple-cell bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the foot and calf of a patient. The Controller is connected to the Patient Sleeve using two independent Flange Ports and can be mounted directly onto the Patient Sleeve for a completely ambulatory system. The Flange Ports allow the air from the Controller to control the compression action on the Calf go Foot Zones independently. The Controller is a lightweight (less than 1 Ib), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy.
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