(352 days)
The device is a product which changes people's position from standing to sitting or sitting to standing and any position in between. The product provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it should not be driven in the standing position on uneven ground.
The device changes people's position in/from seating or/to standing but also any position in between. It provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it is not allowed to drive in standing position on uneven ground. The device is powered by a 24 V DC/36 Ah, lead-acid battery, approximate driving range on fully charged battery is up to 32 km(19 miles), depending on use and the terrain the wheelchair is driven on, and which maximum speed is up to 8 km/h (5 mph). The device is middle wheels with motors driven and controlled by the DYNAMIC DX2 controller.
The provided text describes a 510(k) summary for the EOR 1 Stand-Up Power Wheelchair, focusing on its substantial equivalence to a predicate device and compliance with various international standards. It does not contain information about the acceptance criteria or a study proving device performance in the context of clinical or AI-powered diagnostic devices.
Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, or MRMC studies, as this information is not present in the provided document. The document focuses on establishing equivalence for a physical medical device (a wheelchair).
§ 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).