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510(k) Data Aggregation

    K Number
    K024329
    Device Name
    JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
    Manufacturer
    JI-EE INDUSTRY CO., LTD.
    Date Cleared
    2003-03-21

    (85 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 device is intended for medical purposes to provide mobility to persons restricted to u seated position.

    Device Description

    JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "JI-EE Electric Scooter, Elegance ES 3" and related administrative information. It does not contain any information regarding acceptance criteria, study details, performance metrics, or ground truth establishment for a medical device's performance.

    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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