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510(k) Data Aggregation

    K Number
    K040097
    Device Name
    MEDLINE STRIDER MIDI 3
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2004-02-13

    (24 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to persons that have difficulty walking for prolonged periods of time. They are intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.

    The Medline Strider MIDI 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Medline Strider MIDI 3), not a study report. It does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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