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    K Number
    K161209
    Device Name
    Cirona 6400
    Manufacturer
    DEVON MEDICAL PRODUCTS
    Date Cleared
    2016-05-31

    (33 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Cirona 6400

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cirona 6400 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

    This device can be used in the 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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter for the Cirona 6400 Disposable Deep Vein Thrombosis Prevention System, which confirms its substantial equivalence to predicate devices and outlines its intended use. It does not include details about performance testing, sample sizes, expert qualifications, or ground truth methodologies.

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