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510(k) Data Aggregation

    K Number
    K011687
    Device Name
    MP-3C POWER BASE CHAIR, MODEL MP3C
    Manufacturer
    MERITS HEALTH PRODUCTS., INC.
    Date Cleared
    2001-08-03

    (64 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 :

    MP-3C POWER BASE CHAIR, MODEL MP3C

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

    The intended use of the MP3C is to provide mobility to adults, who have the capability to operate a few simple controls and the ability to control a power wheelchair.

    Device Description

    MP3C Power Base Chair, Model MP3C

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a power-operated chair, the "MP3C Power Base Chair, Model MP3C". It states that the device is substantially equivalent to legally marketed predicate devices.

    This document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth, or an MRMC comparative effectiveness study.

    The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.

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