WU'S 4-WHEELED NEO SCOOTER, WT-M4JR

• K Number: K032489
• Device Name: WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
• Manufacturer: WU'S TECH CO., LTD.
• Date Cleared: 2003-09-24 ( 43 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 4-WHEELED NEO SCOOTER, WT-M4Jr

AI/ML Overview

I'm sorry, but this document is a 510(k) clearance letter from the FDA for a "WU's 4-Wheeled Neo Scooter, WT-M4Jr," which is classified as a "Motorized Three-Wheeled Vehicle."

The provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to a medical device's performance evaluation using AI or clinical studies.

The letter simply states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include any performance data or study details that would be necessary to answer your questions.

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).