(a) Identification. A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety.
(b) Classification. Class III (premarket approval).
(c) Date a PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See Sec. 882.3. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 60 FR 43969, Aug. 24, 1995; 62 FR 30457, June 4, 1997; 73 FR 34860, June 19, 2008]