LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022698
    Device Name
    SCOOTER MARS SERIES, MODEL TL-588
    Manufacturer
    TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
    Date Cleared
    2002-12-02

    (111 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SCOOTER MARS SERIES, MODEL TL-588

    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 seated position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a motorized three-wheeled vehicle (Scooter Mars Series, Model TL-588). It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

    The letter explicitly states that the device is a "Motorized three-wheeled vehicle" and is regulated under "890.3800," which corresponds to "Motorized three-wheeled vehicle" in the FDA's classification database. This is a physical device, not a software-based AI/ML device.

    Therefore, I cannot provide the requested information. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance are relevant to AI/ML device evaluations, not to the traditional medical device approval process for a motorized scooter described in this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1