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510(k) Data Aggregation

    K Number
    K023148
    Device Name
    EPW POWERED WHEELCHAIR, GP-201
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2003-01-24

    (126 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K040320,K062888
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    EPW Powered Wheelchair GP-201 Series

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the EPW Powered Wheelchair GP-201. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

    Therefore, I cannot provide the requested information based on the given input. The document is solely concerned with the regulatory clearance of the device as substantially equivalent to legally marketed predicate devices.

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