WU'S 3-WHEELED NEO SCOOTER, WT-T3B

• K Number: K023168
• Device Name: WU'S 3-WHEELED NEO SCOOTER, WT-T3B
• Manufacturer: WU'S TECH CO., LTD.
• Date Cleared: 2003-01-24 ( 123 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

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

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The text is a U.S. FDA 510(k) clearance letter for a "Wu's 3-Wheeled Neo Scooter, WT-T3B." It primarily focuses on the regulatory determination of substantial equivalence to a predicate device and outlines the general controls and regulations applicable to the product. It states the indications for use as "The device is intended for medical purposes to provide mobility to persons restricted to a seated position."

The letter does not include any technical or clinical study details that would allow me to answer your specific questions regarding performance metrics or study design.

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).