TMC ELECTRICAL SCOOTER, EASY 405

• K Number: K031313
• Device Name: TMC ELECTRICAL SCOOTER, EASY 405
• Manufacturer: TMC TECHNOLOGY CORP.
• Date Cleared: 2003-09-04 ( 133 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: 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 is a 510(k) premarket notification for a medical device called "TMC Electrical Scooter, Easy 405." The document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a letter from the FDA to TMC Technology Corporation, stating that their device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements that the company must comply with. The enclosure mentions the "Indications for Use" for the device, which is "intended for medical purposes to provide mobility to persons restricted to a seated position."

Therefore, I cannot provide the requested information. This document is a regulatory approval letter, not a study report.

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).