§ 882.5800 - Cranial electrotherapy stimulator.

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Identification. A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety.

Classification. Class III (premarket approval).

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.