SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS

• K Number: K020100
• Device Name: SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 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 SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs 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

This is a 510(k) clearance letter for a series of wheelchairs, not a study report for an AI/ML powered device. The document does not contain information about acceptance criteria or a study proving that a device meets such criteria because it pertains to a different type of medical device and regulatory process.

Therefore, I cannot provide the requested information based on the given input.

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).