(293 days)
The helio wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.
The helio is a traditional folding cross-brace wheelchair. It is made of lightweight hi-Modulus carbon fiber mixed with epoxy resin similar to what is used on existing products such as K915533. The frame utilizes one patented cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum caster housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 back tubes are inserted to the desired height. Backrest upholstery is affixed to the back tubes. Armrests receivers bolt onto the rear of each side frame. Individual swing away armrests are then inserted into the receivers. If flip back armrests are chosen, a receiver is mounted onto the front of each side frame to catch the forward most section of the arm and the rear mounting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Footrests with footplates attach at the front of the chair. There is a plug at the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is inserted 90 degrees away from the frame and rotates inwards. The latch will engage once the footrest hanger is centered.
The provided document is a 510(k) Pre-market Notification for a manual wheelchair and does not contain information about an AI/ML device or its acceptance criteria from a study.
Therefore, I cannot provide a response to your request, as it pertains to AI/ML device performance and testing, which is not present in the document.
§ 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).