§882.5805. Repetitive transcranial magnetic stimulation system. — Inbound Citations
21 C.F.R. § 882.5805
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 882.5805 as a whole
-
(a) A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.