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K Number
K032645
Device Name
JUSTWIN SCOOTER, JS-3014
Manufacturer
JOY RIDE TECH CO., LTD.
Date Cleared
2003-12-02

(97 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

JUSTWIN SCOOTER, JS-3014

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "JUSTWIN SCOOTER, JS-3014". This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The letter primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It does not detail the technical performance studies and their results.

§ 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).