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K Number
K022369
Device Name
COMFORT WINDJOY SCOOTER, MODEL LY-EW302
Manufacturer
COMFORT ORTHOPEDIC CO. LTD.
Date Cleared
2002-10-11

(81 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
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

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle (scooter) and does not contain the information needed to answer the questions about acceptance criteria and a study proving device performance. The letter simply states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the provided 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).