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510(k) Data Aggregation

    K Number
    K031314
    Device Name
    TMC ELECTRICAL SCOOTER, EASY 411
    Manufacturer
    TMC TECHNOLOGY CORP.
    Date Cleared
    2003-09-04

    (133 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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

    TMC Electrical Scooter, Easy 411

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "TMC Electrical Scooter, Easy 411". This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:

    • Confirming the substantial equivalence of the device to a predicate device.
    • Outlining regulatory requirements for marketing the device.
    • Stating the intended use of the device.

    To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the device's performance and the methods used to evaluate it.

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