The ONDAMED System
The U.S. FDA regulation states:
Sec. 882.5050 Biofeedback device.
(a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.[44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998]