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510(k) Data Aggregation

    K Number
    K063474
    Device Name
    ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2006-12-22

    (36 days)

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

    ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as it is not a technical report or scientific publication describing a clinical study or algorithm performance. Therefore, I cannot extract the requested information.

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