DOMINATOR

• K Number: K983681
• Device Name: DOMINATOR
• Manufacturer: IMPACT WHEELCHAIR MANUFACTURE, INC.
• Date Cleared: 1998-11-27 ( 38 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The intended use of the device is in providing mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Dominator," manufactured by Impact Wheelchair Manufacture Inc. It declares the device substantially equivalent to a predicate device but does not contain information on acceptance criteria or a study proving the device meets these criteria. Therefore, I cannot provide the requested information based on this document.

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).