(142 days)
The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is extremely stable and durable and it is designed to carry up to 250 pounds on our standard unit and 400 pounds on our heavy duty unit. It is capable of operating over smooth indoor surfaces, or moderately rough, moderately soft, and uneven outdoor surfaces. It is capable of negotiating small obstacles and its spring suspension provides for a smooth ride and easier handling.
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The provided text is a 510(k) clearance letter from the FDA for a power wheelchair. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the format requested. The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory compliance.
Therefore, I cannot provide the requested information.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).