DELUXE MANUAL WHEELCHAIR HW 4000

• K Number: K022700
• Device Name: DELUXE MANUAL WHEELCHAIR HW 4000
• Manufacturer: FOREVER YOUNG ENT. CO., LTD.
• Date Cleared: 2002-09-13 ( 31 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• 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 sitting position.

Device Description

DELUXE MANUAL WHEELCHAIR HW4000

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a Deluxe Manual Wheelchair HW4000. It is a regulatory document from the FDA acknowledging substantial equivalence to a predicate device.

This document does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth methodologies for an AI/ML powered medical device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a manual wheelchair and not an AI-powered device. The questions posed are highly specific to AI/ML device evaluations, which are not applicable to the content of 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).