(46 days)
The EZ Chair will be used, like a Sunrise Medical Quickie 2 HP wheelchair in the Hemi Height position, to aid the temporarily or permanently mobility impaired individual to move about indoors, and outdoors, through the use of a wheeled device (wheelchair). You can propel yourself by pushing along the ground with your feet or you can propel yourself by pushing the pedals. Like a Hemi Height chair, the EZ Chair will be used by people with limited use of their legs due to conditions such as: Arthritis, Single leg Amputee, Multiple Sclerosis, Muscular Dystrophy, Hemiplegic, Parkinson's Disease, Emphysema, Geriatric, Cerebral Palsy, Head Injury, Post Polio, etc.
EZ CHAIR
I am sorry but this document does not contain the information you requested regarding acceptance criteria and study details for the EZ Chair. The provided text is a 510(k) clearance letter from the FDA, which outlines the regulatory approval for the device based on substantial equivalence to a predicate device. It does not include specific performance studies or acceptance criteria beyond indicating its intended use.
§ 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).