USA (FDA code of Federal Regulations) : The SCENAR device, Biofeedback-controlled electro-stimulator, is regulated by the United States Food and Drug Administration, under 21 CFR 882.5050, Generic Name: Device, Biofeedback, Product Code HCC, Class II exempt from 510(k) pre-market notification according to FDA. Notice (Federal Register), Jan. 21, 1998, p. 84) as a battery-powered, professional use device for relaxation training and muscle reeducation. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=882.5050
EUROPE : The SCENAR device has received a CE-mark in Europe (CE 60906 BSI).
AUSTRALIA : The SCENAR device listed on the Australian Register of Australian Goods (ARTG). The registration listing number is 101783.
