Bioness Inc. Receives FDA Clearance and CE Mark for Its NESS H200 Wireless System for Hand Paralysis as a Result of Stroke and Other Central Nervous System Disorders
VALENCIA, Calif., Oct. 4, 2011 /PRNewswire/ -- Bioness Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark Approval by the European Union for its NESS H200® Wireless Hand Rehabilitation System. This new wireless system allows patients to better integrate the NESS H200 into daily life, increasing therapy time which may lead to increased patient compliance and better outcomes.
The NESS H200 Wireless is an advanced hand rehabilitation system designed to use mild Functional Electrical Stimulation (FES) to improve hand function and promote motor recovery in patients who have lost function of their upper extremity following injury to the central nervous system such as stroke, traumatic brain injury or spinal cord injury. The device is intended to provide certain individuals with hand paralysis the ability to grasp and release objects while performing ordinary and essential activities of daily living.
"It is well known in rehabilitation that frequency of therapy and training has a direct impact on outcomes. Simply put, the more patients are able to be active and integrate therapy into their day to day lives, the better their outcomes," said Todd Cushman, Senior Vice-President of Global Business Development and Marketing for Bioness. "Our NESS H200 wireless device provides millions of stroke survivors that suffer hand paralysis a way to seamlessly and practically incorporate hand and arm activity into everyday life, allowing for increased therapy time with improved outcomes."
The device consists of three components: a wireless, lightweight and comfortable functional stimulation support (orthosis); a small handheld control unit that communicates wirelessly with the system; and a clinician's programmer that allows for easy programming and patient activity tracking. Designed for use in both the rehabilitation setting and the home, the NESS H200