MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33

• K Number: K020002
• Device Name: MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
• Manufacturer: TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
• Date Cleared: 2002-03-21 ( 78 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Abbreviated
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The intended use of the P-33 is to provide mobility to adults with the capacity to maintain a seated position on the scooter and have the capacity to operate a simple hand control.

Device Description

Model P-33, Three Wheel Electric Scooter

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a "P-33, Battery Operated, Three-Wheel Electric Scooter." This document is a regulatory approval, not a scientific study describing acceptance criteria and device performance data from a clinical trial or evaluation study.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from the provided text. The document does not contain any of these technical details about device testing or evaluation.

Regulation Number and Section

§ 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).