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K Number
K024329
Device Name
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
Manufacturer
JI-EE INDUSTRY CO., LTD.
Date Cleared
2003-03-21

(85 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 u seated position.

Device Description

JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "JI-EE Electric Scooter, Elegance ES 3" and related administrative information. It does not contain any information regarding acceptance criteria, study details, performance metrics, or ground truth establishment for a medical device's performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

§ 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).