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510(k) Data Aggregation

    K Number
    K050941
    Device Name
    BRIX WHEELCHAIR
    Manufacturer
    MEYRA, INC.
    Date Cleared
    2005-05-05

    (21 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    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 BRIX wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.

    Device Description

    BRIX wheelchair

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA to Meyra, Inc. regarding their BRIX mechanical wheelchair.

    This document is a regulatory clearance notice, confirming that the FDA has found the BRIX wheelchair to be substantially equivalent to legally marketed predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as typically found in a study report for a medical device.

    Therefore, I cannot fulfill your request for the detailed information you've asked for, as it is not present in the provided text. This document is a legal and regulatory clearance for market entry, not a technical study report.

    If you have a different document that details the performance study for the BRIX wheelchair, I would be happy to analyze it for the information you've requested.

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