LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021371
    Device Name
    SUNSPEX TECHNOLOGIES MODEL SE 02
    Manufacturer
    SUNPEX TECHNOLOGY CO., LTD.
    Date Cleared
    2002-05-16

    (16 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Model SE 02 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

    Device Description

    Model SE 02, Three Wheel Electric Scooter

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device: "Model SE 02, Three Wheel Electric Scooter". This letter primarily discusses regulatory approval based on substantial equivalence and does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm performance.

    Therefore, I cannot provide the requested information. The document is a regulatory approval notice, not a study report or technical specification sheet.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1