LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030355
    Device Name
    COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2003-05-20

    (106 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    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 device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB202

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. It generally states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1