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510(k) Data Aggregation

    K Number
    K232640
    Device Name
    Venowave VW5
    Manufacturer
    Thermabright
    Date Cleared
    2024-06-25

    (305 days)

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

    Thermabright

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following: Indications for Use: - Management of the symptoms of post thrombolytic syndrome (PTS) - Prevention of deep vein thrombosis (DVT) - Prevention of primary thrombosis - Treatment of lymphedema - Diminishing post-operative pain and swelling - Treatment of leg swelling due to vascular insufficiency - Treatment of varicose veins - Treatment of chronic venous insufficiency - Enhancing blood circulation - Treatment of intermittent claudication
    Device Description
    The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion, and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently, an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6;VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series.
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