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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR882.5800]
 See Related Information on 882.5800 in CDRH databases



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 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.

[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]

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