EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS

• K Number: K020094
• Device Name: EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS
• Manufacturer: REGULATORY INSIGHT, INC.
• Date Cleared: 2002-03-08 ( 56 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The EN 600-658, EN 600-666, EN 600-664, EN 600-664, EN 600-690, EN 600-6 151, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchats are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a line of wheelchairs, indicating that they have been found substantially equivalent to predicate devices. It does not contain any details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

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).