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510(k) Data Aggregation

    K Number
    K024325

    Validate with FDA (Live)

    Device Name
    JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
    Manufacturer
    JI-EE INDUSTRY CO., LTD.
    Date Cleared
    2003-04-04

    (99 days)

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

    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

    Device Description

    JI-EE Electric Scooter, Esthete ES 1

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a medical device (JI-EE Electric Scooter, Esthete ES 1). It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the given input, as it is not present in the document.

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