(81 days)
The TEFTEC Corporation FirstClass™ Power Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.
The FirstClass™ Power Recline Seating System could provide pressure relief by postural change for persons having the following condition or injury:
Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Sclerosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke)
This is not meant to be an all-inclusive list, anyone needing pressure relief or positional change that is unable to facilitate those movements independently would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.
FirstClass™ Power Recline Seat System Model S500
This document is a 510(k) premarket notification decision letter for the FirstClass™ Power Recline Seat System Model S500. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot extract the requested information from the provided text.
The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
This indicates that the FDA's decision is based on a finding of "substantial equivalence" to a legally marketed predicate device, rather than on a study demonstrating the device meets specific performance acceptance criteria. The document does not describe any specific performance tests, data analysis, or clinical study results.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).