The biofeedback devices are registered as a class two medical device by government health departments in the United States.  They are in the process of receiving the CE Mark registration in Europe, South Africa, Australia and Mexico.

Some additional functions were determined by the manufacturer to be worthy of evaluation so a large scale Institutional Review Board study was undertaken (Immune Staff, 2007).  Out of a sample of 97,000 patients and 327,930 biofeedback sessions, only five patients reported any “negative perception.”  None of these cases reported major difficulty.  The vast majority experienced “feeling better,” “stress reduction” and “behavior modification.”  For over 220 reported diseases the system was found to be safe and effective.  There are over 28,000 biofeedback devices in use worldwide, making them some of the most popular and effective devices in history.  These devices are primarily used in hospitals, medical clinics, naturopathic clinics and wellness centers.  After millions of sessions, there have been no official reports of serious adverse events, though precautionary contraindications have been recommended for pacemakers, pregnancy and history of seizures.