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510(k) Data Aggregation

    K Number
    K191107
    Device Name
    Plexus
    Date Cleared
    2019-08-27

    (123 days)

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

    Alleva Medical (D.G.) Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Plexus RP00 Disposable Portable Deep Vein Thrombosis (DVT) Prevention Device is intended to be used in either home or clinical settings for: - · Aiding the prevention of DVT onset - · Enhancing blood circulation in the lower extremities - · Diminishing post-operative pain and swelling - · Reducing wound healing time, and - · Serving as a prophylaxis for DVT for stationary or bedridden individuals · 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
    Device Description
    The Plexus RP100 Portable Deep Vein Thrombosis ("DVT") Prevention Device is an electronic device that helps to prevent the onset of deep vein thrombosis by stimulating blood flow and increasing venous flow velocity. Each RP100 DVT Prevention Device consists of a pump body and a pressure sleeve with internal air bladder. When turned on, the air bladder inside the sleeve will be automatically inflated to a pre-set level, thereby providing intermittent pressure to the calf. The commercial saleable package will consist of two pump units with their sleeves, one for each leg. The unit operates by inflating the air bladder until the pressure reaches 50mmHg. After reaching this pressure level, the unit will automatically deflate for 50 seconds to complete one cycle. Therapy could persist as long as the patient needs or is instructed by their physician. When the therapy ends, the patient simply would turn off the device by the press of a power button.
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