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510(k) Data Aggregation

    K Number
    K192337
    Device Name
    Zeroveno
    Manufacturer
    Date Cleared
    2020-06-22

    (299 days)

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

    Dimedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs. The device is intended to treat the following: - Management of the symptoms of post thrombotic syndrome (PTS) - Prevention of deep vein thrombosis, (DVT) - Treatment of lymphedema - Treatment of leg swelling due to vascular insufficiency - Treatment of varicose veins - Treatment of chronic venous insufficiency
    Device Description
    ZEROVENO is a product designed to distribute the pressure applied to the leg by changing the position of the contact part which supports the load of the leg alternately with the pressing pressure periodically. The swept volume or volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (8cm) and the depth of the wave (1cm) or approximately 0.1 L/cycle. ZEROVENO has a maximum continuous operation time of 20 hours on a low-speed basis when the built-in lithium-ion battery is fully charged.
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