PANTHER WHEELCHAIR

• K Number: K982849
• Device Name: PANTHER WHEELCHAIR
• Manufacturer: SNUG SEAT, INC.
• Date Cleared: 1998-10-05 ( 54 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Panther Wheelchair is designed for children and/or small adults who have physical impairments that require the use of a device to assist them with their mobility needs.

Device Description

Panther Wheelchair

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a wheelchair. It does not contain the specific information requested about acceptance criteria and a study proving device performance for an AI/ML powered device. The letter is for a physical medical device (Panther Wheelchair) and focuses on substantial equivalence to existing devices and regulatory compliance, not algorithmic performance.

Therefore, I cannot extract the requested information from the provided text.

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).