The US FDA has allowed the marketing of the Biomove 3000 for Stroke Rehabilitation by Muscle Re-education. The Biomove 3000 complies with the US Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and patient cables and the device is manufactured according to Good Manufacturing Practice requirements as set forth in the Quality Systems regulation (21 CFR Part 820);
The company has been awarded certification according to ISO 13485 for design, manufacturing, final inspection, distribution and service of electrical therapy devices.
