LogoFDA 510(k) Search
K Number
K030757
Device Name
COACH 777-4
Manufacturer
WHEELCHAIR & SCOOTER EXPRESS
Date Cleared
2003-10-06

(209 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 intended use of this product is to offer another choice of mobility to physically challenged people.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking for. The document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle named "Coach 777-4". It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It does not include information about performance studies, test sets, ground truth, or expert qualifications.

§ 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).