A. The Best Pro 1 (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 FR21ja98-84 as a battery-powered, professional use device for relaxation training and muscle reeducation.Ý The Avazzia Tennant Biomodulator is a Biofeedback Electro-stimulator is a quality medical instrument and accepted by the FDA as a class II device. FDA approval requires that the Avazzia Tennant Biomodulator be used by or upon the recommendation of a licensed health practitioner, thus it is necessary to obtain a copy of the purchaser’s license and keep it in their file. *For those who want it for their own use, we proceed with the following protocol: 1 Complete (in person, via phone or email/fax) a registration form and a doctor/patient contract. 2 A doctor must sign a prescription for them stating, “Use Bes