(51 days)
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.
TC Series [Mechanical Wheelchair]
The provided document is a 510(k) premarket notification letter from the FDA regarding several manual wheelchairs (TC Series). This type of document does not contain acceptance criteria or a study proving that a device meets acceptance criteria.
The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving safety and effectiveness through clinical trials with defined acceptance criteria in the same way a Premarket Approval (PMA) application would.
Therefore, I cannot provide the requested information based on the given input document.
§ 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).