TMC ELECTRICAL SCOOTER, EASY 321

• K Number: K031315
• Device Name: TMC ELECTRICAL SCOOTER, EASY 321
• Manufacturer: TMC TECHNOLOGY CORP.
• Date Cleared: 2003-09-04 ( 133 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Traditional
• Panel: PM
• 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 document is a 510(k) clearance letter for a medical device: the "TMC Electrical Scooter, Easy 321." It primarily serves to inform the manufacturer that their device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

While it mentions the device's intended use ("intended for medical purposes to provide mobility to persons restricted to a seated position"), it does not contain any information about acceptance criteria, device performance metrics, or any studies.

Therefore, I cannot provide the requested information. The document focuses solely on regulatory clearance based on substantial equivalence, not on specific performance data or studies.

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).