LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983763
    Device Name
    SPECTRUM SPIRIT
    Manufacturer
    FREEDOM DESIGNS, INC.
    Date Cleared
    1998-11-23

    (28 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

    This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

    Device Description

    Manual Folding Mobility Wheelchair

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves the device meets acceptance criteria.

    The document is a letter from the FDA to Freedom Designs, Inc., regarding the substantial equivalence of their "Manual Folding Mobility Wheelchair." It primarily discusses regulatory aspects, such as classification, general controls, and marketing authorization. It does not contain any technical specifications, performance metrics, or details of a scientific study evaluating the device's performance against specific criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1