Y.E.S 10 WHEELCHAIR

• K Number: K021255
• Device Name: Y.E.S 10 WHEELCHAIR
• Manufacturer: MOVINGPEOPLE.NET
• Date Cleared: 2002-05-02 ( 13 days)
• Product Code: ITI
• Regulation Number: 890.3860
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The intended use of the movingpeople.net Y•e•S is to provide mobility to persons limited to a seated position and that have the capability of operating a powered wheelchair.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair named "Y.e.S." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document is a regulatory approval letter and DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document focuses solely on the regulatory approval process and not on the technical performance evaluation that would typically include such details.

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).