Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk

Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk

We present device standards for low-power non-invasive electrical brain stimulation devices classified as limited output transcranial electrical stimulation (tES). Emerging applications of limited output tES to modulate brain function span techniques to stimulate brain or nerve structures, including...

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Bibliographic Details
Main Authors: Marom Bikson, Bhaskar Paneri, Andoni Mourdoukoutas, Zeinab Esmaeilpour, Bashar W. Badran, Robin Azzam, Devin Adair, Abhishek Datta, Xiao Hui Fang, Brett Wingeier, Daniel Chao, Miguel Alonso-Alonso, Kiwon Lee, Helena Knotkova, Adam J. Woods, David Hagedorn, Doug Jeffery, James Giordano, William J. Tyler
Format: Article
Language:English
Published: Elsevier 2018-01-01
Series:Brain Stimulation
Subjects:
Limited output tES
FDA clearance
Over-the-counter device
Prescription medication
FDA product codes
Manufacturer guidance
Online Access:http://www.sciencedirect.com/science/article/pii/S1935861X17309452

Internet

http://www.sciencedirect.com/science/article/pii/S1935861X17309452

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