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510(k) Data Aggregation

    K Number
    K992884
    Device Name
    WHEELCHAIR (MANUAL, NOT ELECTRICAL)
    Manufacturer
    FOSHAN MACHINERY & EQUIPMENT IMPORT & EXPORT CO.
    Date Cleared
    1999-11-02

    (69 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K041814
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    In order to transport patient(s) and/or disable people This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.

    Device Description

    WHEEL CHAIR(MANUAL,NOT ELECTRICAL)

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a manual wheelchair, not a study report for an AI/ML medical device. Therefore, it does not contain any of the requested information regarding acceptance criteria or a study proving device performance for an AI-based system.

    The document describes a manual wheelchair (not electrical) and states that its intended use is to "transport patient(s) and/or disable people." It specifies that "someone (nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concrete road, pavement, sudd floor for the safety and effectiveness."

    Since this is a clearance for a simple mechanical device, the concepts of acceptance criteria for an AI model, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the information contained in these documents.

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