Rehabtek develops and manufactures portable robotic rehabilitation technology, centered on Stretch&Move, an ankle-training system that combines intelligent stretching with active movement. Based on research into neurological and orthopedic impairments—including studies involving children with cerebral palsy—the Linthicum Heights company focuses on affordable devices that help restore joint motion, muscle strength, and motor control. Its development and manufacturing facility operates under FDA 21 CFR 820 requirements, while Stretch&Move has Intertek electrical and EMC safety certification.
FDA Registration
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FDA 21 CFR 820 Quality System Regulation
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ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
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Intertek Electrical and EMC Safety Certification
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IEC 60601-1-6:2010/AMD1:2013
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IEC 60601-1:2005/AMD1:2012
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IEC 62304:2006/AMD1:2015
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IEC 60601-1-2 (Edition 4) 2014
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