21 C.F.R. § 882.5800 Cranial electrotheraphy stimulator.
Title 21 - Food and Drugs
(a) Identification. A cranial electrotheraphy 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 §882.3. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 60 FR 43969, Aug. 24, 1995; 62 FR 30457, June 4, 1997]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§ 882.5800 Cranial electrotheraphy stimulator.
