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510(k) Data Aggregation

    K Number
    K993032
    Device Name
    MODIFICATION TO MP-3 POWER BASE CHAIR
    Manufacturer
    MERITS HEALTH PRODUCTS., INC.
    Date Cleared
    1999-11-05

    (87 days)

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

    MODIFICATION TO MP-3 POWER BASE CHAIR

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

    Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.

    Device Description

    MP-3 Power Base Chair

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (MP-3 Power Base Chair) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device and provides regulatory guidance for marketing.

    Therefore, I cannot provide the requested information.

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