(57 days)
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Manual Wheelchair (K992035). This document does not describe acceptance criteria, performance studies, or any of the specific details requested in your prompt regarding a device's performance evaluation.
This type of FDA letter is an acknowledgement that a medical device manufacturer has demonstrated to the FDA that their device is substantially equivalent to a legally marketed predicate device. It signifies regulatory clearance to market the device, not a detailed technical performance report.
Therefore, I cannot extract the requested information from the provided 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).