WU'S 3-WHEELED NEO SCOOTER, WT-L3

• K Number: K023040
• Device Name: WU'S 3-WHEELED NEO SCOOTER, WT-L3
• Manufacturer: WU'S TECH CO., LTD.
• Date Cleared: 2003-01-24 ( 134 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

Wu's 3-Wheeled Neo Scooter, WT-L3

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a "Wu's 3-Wheeled Neo Scooter, WT-L3," which is classified as a "Motorized, three-wheeled vehicle."

This document does not contain any information about:

• Acceptance criteria or device performance for medical imaging or AI analysis.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, or ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.

The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for providing mobility to persons restricted to a seated position. It pertains to a physical medical device, not a software or AI-driven diagnostic tool.

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).