(14 days)
Chunc pediatic attendant controlled wheelchair is intended for clients with moderate to specialists. The controlled by the for the last controlled needs first and foremost. Chunc pediatic attendant controlled wheeledall 15 michood attendents needs first and foremost.
Chunc manual wheelchairs empower physically challenged persons by providing a means of ten and and contract and annonemant conditions swch as: Chunc manual whicheman's chiponery and permanent conditions such as: Arthritis, Amputee, Paraplegia, Muscular Dystrophy, Tetraplegia, Quadriplegia, Spina Bifida, and any other immobilizing or debilitating condition, Multiple Sclerosis, Polio, Cerebral Palsy.
The modular design of the wheelchair chassis, frame and seating allows for flexibility and ease of The modular design of the wheelchard and social needs. This coupled with material choice and the frequent use of like parts across the when associated us to keep costs at a numming the frequent use of like parts actoss to be easily identifies a for any increase tunctions using unified adjustments with color coding which are also simple to see and maintain. By moving away from the cumbersome welded steel structures of conventional wheelchairs we have been away from the cumbersome welcen steer surverling of envired to envire the wheelchair is lightweight and therefore comfortable to use. Chunc is carrently manifactured and marketed the lightweight and therefore comical by the National Health Service (NHS) and has the relevant CES marking. Chunc also provides the ability for Bus Transportation and notest that meet the marking. Chunc also provides the ability to: Dos Transportation and occupants (WTORS) that meet the requirements of SAE J2249
The provided document is a 510(k) clearance letter from the FDA for two wheelchair models (Chunc Junior Model# Sm 242, Chunc Adapt Model # Sm 251). This type of document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) clearance process is based on demonstrating substantial equivalence to a predicate device, not necessarily on performance against specific acceptance criteria derived from a clinical study. It primarily focuses on the device's intended use, technological characteristics, and safety and effectiveness compared to an already legally marketed device.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies) from this document. This information is typically found in design validation reports or clinical study summaries, which are not part of the 510(k) clearance letter itself.
§ 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).