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K Number
K991281
Device Name
ELECTRIC MOBILITY CAVALIER SCOOTERS
Manufacturer
ELECTRIC MOBILITY CORP.
Date Cleared
1999-10-27

(196 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 Electric Mobility Cavalier Scooter is intended to serve the needs of individuals who have limited mobility.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA to Electric Mobility Corporation for their "Cavalier Scooters". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulations the company must follow.

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).