LogoFDA 510(k) Search
K Number
K032643
Device Name
JUSTWIN SCOOTER, JS-3013
Manufacturer
JOY RIDE TECH CO., LTD.
Date Cleared
2003-12-02

(97 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 a seated position.

Device Description

JUSTWIN SCOOTER, JS-3013

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "JUSTWIN SCOOTER, JS-3013". This document is a regulatory approval notice and does not contain information about acceptance criteria, device performance, study data, or clinical trials that would address the questions posed.

Therefore, I cannot provide the requested information based on the given text.

§ 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).