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510(k) Data Aggregation

    K Number
    K031313
    Device Name
    TMC ELECTRICAL SCOOTER, EASY 405
    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

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device called "TMC Electrical Scooter, Easy 405." The document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a letter from the FDA to TMC Technology Corporation, stating that their device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements that the company must comply with. The enclosure mentions the "Indications for Use" for the device, which is "intended for medical purposes to provide mobility to persons restricted to a seated position."

    Therefore, I cannot provide the requested information. This document is a regulatory approval letter, not a study report.

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