QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424

• K Number: K031289
• Device Name: QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
• Manufacturer: SUNRISE MEDICAL, INC.
• Date Cleared: 2003-05-09 ( 16 days)
• Product Code: ITI
• Regulation Number: 890.3860
• Type: Special
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The Center Drive Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) summary for the "Center Drive Power Wheelchair" (K031289) does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth establishment, expert involvement, or training sets.

This document is a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, and an "Indications for Use Statement." It does not include the detailed technical and performance data that would typically be found in a study report.

Therefore, I cannot provide the requested information based on the text you provided.

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).