[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
[CITE:21CFR882.5800]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
PART 882 — NEUROLOGICAL DEVICES
Subpart F–Neurological Therapeutic Devices
Sec. 882.5800 Cranial electrotherapy stimulator.
(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]