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510(k) Data Aggregation

    K Number
    K050560
    Device Name
    EUROCHAIR
    Manufacturer
    MEYRA, INC.
    Date Cleared
    2005-04-21

    (49 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 EUROCHAIR wheelchair family is designed mainly for adults with physical impairments that require the use of a device to assist them with their mobility needs.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a mechanical wheelchair called "Eurochair." This document does not contain information about acceptance criteria or a study proving the device meets said criteria.

    The letter confirms that the FDA has reviewed the 510(k) submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that the device is deemed as safe and effective as a device already on the market, but it does not detail specific performance criteria or the results of a study to demonstrate that.

    Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative letter granting market clearance based on substantial equivalence.

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