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Regulatory certifications
The US FDA has allowed the marketing of the Biomove 3000 and Biomove 5000 devices for Stroke Rehabilitation by Muscle Re-education.
The Biomove systems comply 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 Biomove 3000 and Biomove 5000 have been cleared by the US FDA.
View FDA clearance
View FDA clearance
The Biomove devices have been CE certified according to the European Medical Device Directive.
View CE Certificate
The company has been awarded certification according to ISO 13485 for design, manufacturing, final inspection, distribution and service of electrical therapy devices.
View ISO 13485 Certificate
