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510(k) Data Aggregation

    K Number
    K193662
    Device Name
    Ezlymph, Ezlymph M
    Date Cleared
    2021-02-11

    (408 days)

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

    Eezcare Medical Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EzLymph and EzLymph M are intended to treat lymphedema.
    Device Description
    EzLymph and EzLymph M is a pump system intended to apply intermittent pneumatic compression (IPC) to arms and legs to relieve the discomfort of lymphedema. The device helps move the flow of lymphatic and venous fluid throughout the extremities by stimulating muscles within the affected extremity. This action mimics natural muscle contractions, improves circulation, and moves excess fluid back to the circulatory system so edema can be eliminated from the body. System components include (a) a mains-powered, portable pneumatic pump with a pressure-control knob and on/off switch (the device contains no control panel or microprocessor circuit); (b) connecting air hoses; and (c) compression garments attached to patient limbs. In addition, garment inserts allow increase in circumference of arm and leg garments. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's upper and lower limbs (full arm, full leg, and half leg).
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    K Number
    K191937
    Device Name
    Ezvena IPC, Ezvena SQS
    Date Cleared
    2020-01-29

    (194 days)

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

    Eezcare Medical Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.
    Device Description
    EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs. The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. System components include a mains-powered, pneumatic pump with touch-input control panel and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs. Compression is uniform in the IPC model and graded sequential in the SQS model. The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS.
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