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Comparable to the special controls for device classification 21 CFR 882.5801 Computerized behavioral therapy device for psychiatric disorders, the 21 CFR 882.5803 device classification's special controls require the use of a validated measure to evaluate effectiveness of the device to provide therapy for ADHD or any of its individual symptoms

Clinical studies suggest that any increase in metabolic rate is usually small, and effects may diminish as the body develops tolerance to stimulant-based products over time

The final concentration of HGF in media was set at 5 ng/ml, which has been shown to maximally activate satellite cells in our primary culture system 19