MECHANICAL DAILY USE WHEELCHAIR

• K Number: K021075
• Device Name: MECHANICAL DAILY USE WHEELCHAIR
• Manufacturer: FIRST WORLD SERVICES, INC.
• Date Cleared: 2002-07-12 ( 101 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: K200135

Intended Use

The device is a mechanical wheelchair with wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.

Device Description

The device is a mechanical wheelchair with wheels that are turned manually.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a "Mechanical Daily Use Wheelchair." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The information you are asking for typically comes from a substantial equivalence report or other premarket submission documents, which are not provided here.

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).