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510(k) Data Aggregation

    K Number
    K990463
    Device Name
    MEDLINE EXCEL WHEELCHAIRS
    Manufacturer
    MEDLINE
    Date Cleared
    1999-03-15

    (31 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

    Medline Excel Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the Medline Excel Wheelchairs. It does not contain any information about acceptance criteria or a study proving device performance as it pertains to a medical device software (AI/ML) product. This document is a regulatory approval for a physical medical device (wheelchair) and does not involve AI performance metrics. Therefore, I cannot extract the requested information from the provided text.

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