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K Number
K030756
Device Name
COACH 777-3
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

To provide an optional means of mobility for physically challenged people.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device named "Coach 777-3," which is a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria for device performance, reports of device performance, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document solely states that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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