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510(k) Data Aggregation

    K Number
    K032669
    Device Name
    Y.E.S. POWERED WHEELCHAIR, MODEL T200
    Manufacturer
    YEOU EIR SHUEN MACHINERY CO., LTD.
    Date Cleared
    2003-11-12

    (76 days)

    Product Code
    ITN,ITI
    Regulation Number
    890.3675
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Y.E.S. POWERED WHEELCHAIR, MODEL T200

    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

    Y.E.S. Powered Wheelchair, T200

    AI/ML Overview

    I am sorry, but the provided text does not contain information on acceptance criteria, study details, or device performance for the Y.E.S. Powered Wheelchair, T200. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include the specifics of performance testing or clinical studies.

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