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510(k) Data Aggregation

    K Number
    K032645
    Device Name
    JUSTWIN SCOOTER, JS-3014
    Manufacturer
    JOY RIDE TECH CO., LTD.
    Date Cleared
    2003-12-02

    (97 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 a seated position.

    Device Description

    JUSTWIN SCOOTER, JS-3014

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "JUSTWIN SCOOTER, JS-3014". This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given input. The letter primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It does not detail the technical performance studies and their results.

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