CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART F—Neurological Therapeutic Devices (§882.5030 to §882.5975) > 882.5800—Cranial electrotherapy stimulator.

882.5800—Cranial electrotherapy stimulator.

(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 § 882.3.

Code of Federal Regulations

[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; 73 FR 34860, June 19, 2008]