21 C.F.R. § 882.5235 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — MEDICAL DEVICES — NEUROLOGICAL DEVICES — NEUROLOGICAL THERAPEUTIC DEVICES — Aversive conditioning device
(a)Identification. An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.
(b)Classification. Class II (special controls), except for electrical stimulation devices for self-injurious or aggressive behavior. Electrical stimulation devices for self-injurious or aggressive behavior are banned. See § 895.105 of this chapter.