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510(k) Data Aggregation

    K Number
    K012802
    Device Name
    MP3CF ELECTRIC WHEELCHAIR
    Manufacturer
    MERITS HEALTH PRODUCTS., INC.
    Date Cleared
    2001-09-18

    (28 days)

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

    MP3CF ELECTRIC WHEELCHAIR

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

    The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a powered wheelchair, the MP3CF. It declares substantial equivalence to a predicate device.

    There is no information in the provided text regarding acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is strictly an FDA clearance letter.

    Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed, subject to general controls and potentially additional special controls.

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