21 C.F.R. § 882.5940 Electroconvulsive therapy device.
Title 21 - Food and Drugs
(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 §882.3. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§ 882.5940 Electroconvulsive therapy device.
