TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR

• K Number: K033031
• Device Name: TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
• Manufacturer: TAIWAN KING STRONG CO., LTD.
• Date Cleared: 2003-12-02 ( 67 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The device is intended for medical purposes to provide mobility to person restricted to a sitting position.

Device Description

TAIWAN KING STRONG TC03MECHANICAL WHEELCHAIR

AI/ML Overview

I am sorry, but this document is an FDA 510(k) clearance letter for a mechanical wheelchair. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a performance study against specific acceptance criteria for a novel technology like AI.

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).