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
Registration
FDA 21 CFR 820 Quality System Regulation
Compliance program
ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
Compliance program
Intertek Electrical and EMC Safety Certification
IEC 60601-1-6:2010/AMD1:2013
Compliance program
IEC 60601-1:2005/AMD1:2012
Compliance program
IEC 62304:2006/AMD1:2015
Compliance program
IEC 60601-1-2 (Edition 4) 2014
Compliance program
FDA
Quality certification