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510(k) Data Aggregation

    K Number
    K984565
    Device Name
    TMC-EASY-302
    Manufacturer
    TMC MAGNETICS & MACHINERY CORP.
    Date Cleared
    2000-02-16

    (420 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

    TMC-Easy-302 is intended for use to transport person outside usually by disabled persons. The scooter has a seated position for carrying person in the considerations of ergonomically.
    The scooter's range on a standard charge varies according to temperature and battery condition, but the average range is approximately 20 miles.

    Device Description

    TMC-Easy-302 MOTORIZED THREE-WHEELED SCOOTER

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a motorized three-wheeled scooter. It does not contain information about the acceptance criteria and the study that proves the device meets those criteria.

    Therefore, I cannot extract the requested information from this document.

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