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510(k) Data Aggregation

    K Number
    K033031
    Device Name
    TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
    Manufacturer
    TAIWAN KING STRONG CO., LTD.
    Date Cleared
    2003-12-02

    (67 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    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 person restricted to a sitting position.

    Device Description

    TAIWAN KING STRONG TC03MECHANICAL WHEELCHAIR

    AI/ML Overview

    I am sorry, but this document is an FDA 510(k) clearance letter for a mechanical wheelchair. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a performance study against specific acceptance criteria for a novel technology like AI.

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