(44 days)
The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.
Target population: For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Design: A manual stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
Material: Main frame: Colour painted aluminium. Major stressed parts: Reinforced brass casting. Upholstery: Flame impeded.
I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called "LEVO active-easy LAE", which is a stand-up wheelchair.
The document primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory information and responsibilities. It includes the indications for use and a brief description and performance claim for the device, but this is not a detailed study report or a list of acceptance criteria.
Therefore, I cannot provide the requested information based on the input text.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).