SCOOTER MARS SERIES, MODEL TL-588

• K Number: K022698
• Device Name: SCOOTER MARS SERIES, MODEL TL-588
• Manufacturer: TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
• Date Cleared: 2002-12-02 ( 111 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

This document is a 510(k) premarket notification letter from the FDA regarding a motorized three-wheeled vehicle (Scooter Mars Series, Model TL-588). It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter explicitly states that the device is a "Motorized three-wheeled vehicle" and is regulated under "890.3800," which corresponds to "Motorized three-wheeled vehicle" in the FDA's classification database. This is a physical device, not a software-based AI/ML device.

Therefore, I cannot provide the requested information. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance are relevant to AI/ML device evaluations, not to the traditional medical device approval process for a motorized scooter described in this document.

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).