[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR882.5940]

[Page 443]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 882_NEUROLOGICAL DEVICES--Table of Contents
 
               Subpart F_Neurological Therapeutic Devices
 
Sec. 882.5940  Electroconvulsive therapy device.

    (a) Identification. An electroconvulsive therapy device is a device 
used for treating severe psychiatric disturbances (e.g., severe 
depression) by inducing in the patient a major motor seizure by applying 
a brief intense electrical current to the patient's head.
    (b) Classification. Class III (premarket approval).
    (c) Date 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 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987]