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510(k) Data Aggregation

    K Number
    K122640
    Device Name
    VPULSE
    Manufacturer
    COTHERA, LLC
    Date Cleared
    2013-02-22

    (177 days)

    Product Code
    JOW
    Regulation Number
    870.5800
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    Applicant Name (Manufacturer) :

    COTHERA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VPULSE is intended to function as an intermittent, external compression device in extremities to prevent and reduce complications of poor circulation. This includes: - deep vein thrombosis, . - chronic venous insufficiency, . - venous stasis ulcers, . - . post-mastectomy edema and chronic lymphedema, - reduction of edema associated with soft tissue injuries such as burns. . postoperative edema, and ligament sprains, - localized cold thermal therapy for post-traumatic and post-surgical medical . and/or surgical conditions) - Aids the blood flow back to the heart . - . Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
    Device Description
    The VPULSE system is a device designed to function as a dual intermittent external pneumatic compression device. The intended therapies of the device are dynamic pneumatic compression therapy (DCT) in order to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers, and intermittent sequential pneumatic compression (SCT) in order to reduce the risk of the formation and prevent the occurrence of a pulmonary embolism resulting from a deep vein thrombosis (DVT) - collectively referred to as venous thromboembolism (VTE) - by aiding in the blood flow back to the heart via lower extremity limb compression. The VPULSE system consists of a control unit, tubing set and a family of single-patient applied wraps. The control unit contains a pneumatic pump and air reservoir for inflation of the DCT an SCT wraps, a fluid pump and user filled fluid canister for water circulation into the DCT wrap, and supporting controls to deliver and monitor the modalities. The control unit allows the patient to select and apply the treatment functions concurrently or individually. The tubing set allows the patient to connect the wraps to the control unit and is of a length that allows treatment to be applied in a physical position comfortable for the user. There are two (2) types of wraps given the intended treatment function of DCT and/or SCT. The DCT wraps are typically applied to an acute injury site usually the result of surgery. The SCT wraps are typically applied to the calves.
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