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510(k) Data Aggregation

    K Number
    K030356
    Device Name
    COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2003-05-20

    (106 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103

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

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    COMFORT Powered Wheelchair, Traveller LY-EB103

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a "Comfort Powered Wheelchair, Traveller LY-EB103." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

    The letter does not contain:

    • A table of acceptance criteria and reported device performance.
    • Details about a study conducted to demonstrate performance, including sample sizes, data provenance, ground truth establishment, or expert reviews.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot provide the requested information.

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