(35 days)
The LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.
The LLOYD LINDEN EO4 power standup wheelchair is an indoor/outdoor power stand up wheelchair that is battery operated. The design of this wheelchair is basically similar to other power stand up wheelchairs that are already on the market. It consists primarily of a welded steel frame, transaxle motor drive system, braking system and electronic motor controller and is powered by two 12 volt DC batteries, and utilize a charger.
The provided text pertains to a 510(k) summary for a medical device (a power standup wheelchair) and does not describe any acceptance criteria or a study that proves the device meets those criteria. The submission establishes substantial equivalence to a predicate device based on similar design and intended use, noting only minor performance differences that do not alter function or raise new safety/effectiveness questions.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 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).