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510(k) Data Aggregation

    K Number
    K982066
    Device Name
    MP-3 POWER BASE CHAIR
    Manufacturer
    MERITS HEALTH PRODUCTS., INC.
    Date Cleared
    1998-08-31

    (81 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    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 Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.

    Device Description

    MP-3 Power Base Chair

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a power base chair (MP-3 Power Base Chair). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to the efficacy or safety testing of the device.

    The letter only states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot provide the requested information based on the input document.

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