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510(k) Data Aggregation

    K Number
    K071744
    Device Name
    AVIAFIT PULSATING LEGBAND
    Manufacturer
    FLOWMEDIC LTD.
    Date Cleared
    2007-09-25

    (90 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K111720
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.

    Device Description

    AviaFit™ Pulsating Legband

    AI/ML Overview

    This document is a 510(k) summary for the AviaFit™ Pulsating Legband. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

    Therefore, the requested information cannot be extracted from the provided text. The document confirms the FDA has found the device substantially equivalent to a legally marketed predicate device, but it lacks the specific study details needed to answer the questions about acceptance criteria and performance data.

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