LogoFDA 510(k) Search
K Number
K024325
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
PM
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

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.

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).