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The TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.

The FirstClass™ Power Tilt & 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.

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The provided document is a 510(k) summary for the FirstClass™ Power Tilt & Recline Seat System Model S400. It is a clearance letter from the FDA stating that the device is substantially equivalent to a predicate device.

This document does NOT contain information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, or any of the detailed study parameters requested.

The letter only confirms that the device can be marketed based on its substantial equivalence to pre-existing devices. It does not provide any clinical trial data, performance metrics, or study designs typically associated with proving a device meets specific acceptance criteria.

Therefore, I cannot populate the requested information from the provided text.

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