(55 days)
Our new Wheelchair, Zephyr is not envisioned nor will it be marketed to a first time user but rather directed to a handicapped user who has become relatively proficient in the use of a wheelchair. And who is seeking a lighter and more maneuverable wheelchair for use in sports and athletic enhancement.
Not Found
This document is a FDA 510(k) clearance letter for a mechanical wheelchair named "Zephyr" and does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the given text.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).