(71 days)
This wheelchair is designed as a general purpose utility wheelchair, to be used in, and for, the users day to day living and transportation. It functions as any standard manual wheelchair does, however it is also designed to allow the user to easily and temporarily elevate the seating system to raise the user to a height slightly greater than that of an average able bodied person standing, or any height in between, allowing the user to access high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.
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The provided text is a 510(k) Pre-Market Notification for a medical device called the "New Heights Electric Elevating Manual Wheelchair". This document primarily concerns the FDA's determination of substantial equivalence for marketing purposes.
Crucially, this document does NOT contain information regarding acceptance criteria, study findings, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device in a clinical or scientific study.
The FDA letter and the "Indications for Use" section describe the intended purpose and function of the wheelchair (general utility, elevating feature to reach high shelves). However, there is no mention of tests, studies, or criteria that evaluate the device's performance against specific metrics like safety, effectiveness, or user outcomes beyond its basic functionality.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The information required for your detailed table and subsequent points (1-9) is simply not present in this regulatory filing.
§ 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).