Valencia, CA based Bioness, Inc. has announced that its NESS H200 Wireless Hand Rehabilitation System has been CE Marked and has received FDA 510(k) clearance. Like the company’s previous NESS H200 System, this new system uses functional electrical stimulation (FES) to help restore hand function, reduce muscle spasm, and prevent atrophy in patients who suffer from reduced functionality or complete hand paralysis following a stroke or spinal cord injury. The NESS H200 Wireless improves on the previous NESS H200 offering with its wireless control unit, which improves the device’s portability and ease of use.
The system’s modular design allows for individualized fitting for each patient, and flexible components help maintain contact between the patient’s skin and the device’s electrodes. Additionally, the H200 incorporates Bioness’ clinical electrode location system to automatically determine optimal electrode placement for each patient.
From the press release:
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 Wireless may reduce muscle spasm, prevent muscle atrophy, reeducate muscles, increase local blood circulation and may improve hand activity or range of motion.
Press release: 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
Flashback: NESS H200™ System