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510(k) Data Aggregation

    K Number
    K042652
    Device Name
    TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
    Manufacturer
    TAIWAN KING STRONG CO., LTD.
    Date Cleared
    2004-11-04

    (37 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR

    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

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, indicating that the device is substantially equivalent to a legally marketed predicate device. It does not contain details about specific performance metrics, studies, or ground truth establishment.

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