LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053574
    Device Name
    MEDLINE PEDIATRIC WHEELCHAIRS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2006-01-25

    (34 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

    Medline Pediatric Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Medline Pediatric Wheelchairs) and does not contain information about acceptance criteria, device performance studies, or AI/ML components. Therefore, I cannot generate the requested table and study details based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1