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510(k) Data Aggregation

    K Number
    K033097
    Device Name
    TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
    Manufacturer
    TAIWAN KING STRONG CO., LTD.
    Date Cleared
    2003-11-12

    (44 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02

    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

    TAIWAN KING STRONG Powered Wheelchair, TP02

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for a powered wheelchair (Taiwan King Strong Powered Wheelchair, TP02). This document focuses on regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

    It does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical performance study for AI/software as a medical device.

    Therefore, I cannot extract the requested information regarding AI device performance. This document is related to a physical medical device (a powered wheelchair) and its regulatory clearance process, not an AI/software medical device.

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