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510(k) Data Aggregation

    K Number
    K991281
    Device Name
    ELECTRIC MOBILITY CAVALIER SCOOTERS
    Manufacturer
    ELECTRIC MOBILITY CORP.
    Date Cleared
    1999-10-27

    (196 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electric Mobility Cavalier Scooter is intended to serve the needs of individuals who have limited mobility.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA to Electric Mobility Corporation for their "Cavalier Scooters". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulations the company must follow.

    Therefore, I cannot provide the requested information based on the provided text.

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