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510(k) Data Aggregation

    K Number
    K180389
    Device Name
    Venera 508 Deep Vein Thrombosis (DVT) Prevention System
    Date Cleared
    2018-06-29

    (136 days)

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

    Suzhou Minhua Medical Apparatus Supplies Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Venera 508 Deep Vein Thrombosis (DVT) Prevention Therapy System is a portable treatment to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This system can be applied in either home or clinical settings to: - . Aid in the prevention of DVT - . Enhance blood circulation - . Diminish post-operative pain and swelling - . Reduce wound healing time - . Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs - . As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
    Device Description
    The Venera™ 508 Deep Vein Thrombosis Prevention System is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Venera 508 system consists of a pair of pump and cuff assemblies. The device will alternatively inflate and deflate the garment (cuff) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.
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