(51 days)
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Recliner) 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 (Recliner) [Mechanical Wheelchair]
The provided document is an FDA 510(k) clearance letter for the "TC Series (Recliner) [Mechanical Wheelchair]" and related products. It primarily focuses on the device's substantial equivalence to predicate devices and regulatory compliance. This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed summary of safety and effectiveness.
Therefore, I cannot extract the requested information. The document explicitly states:
- "We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the clearance was based on substantial equivalence to predicate devices, not on a new study proving the device meets specific performance acceptance criteria in the way a clinical trial for a novel, higher-risk device would. For Class I devices like manual wheelchairs, the regulatory requirements are generally less stringent, focusing on general controls rather than extensive clinical efficacy studies.
§ 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).