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510(k) Data Aggregation

    K Number
    K021075
    Device Name
    MECHANICAL DAILY USE WHEELCHAIR
    Manufacturer
    FIRST WORLD SERVICES, INC.
    Date Cleared
    2002-07-12

    (101 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K200135
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a mechanical wheelchair with wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.

    Device Description

    The device is a mechanical wheelchair with wheels that are turned manually.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a "Mechanical Daily Use Wheelchair." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The information you are asking for typically comes from a substantial equivalence report or other premarket submission documents, which are not provided here.

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