(36 days)
The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.
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I am sorry, but this document is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as it is not a technical report or scientific publication describing a clinical study or algorithm performance. Therefore, I cannot extract 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).