eCFR Reference Browser

---

title: "21 CFR §882.5800"

source: "https://www.ecfr.gov/current/title-21/section-882.5800"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "882"

part_subject: "NEUROLOGICAL DEVICES"

subpart_code: "F"

subpart_subject: "Neurological Therapeutic Devices"

section_number: "882.5800"

section_subject: "Cranial electrotherapy stimulator."

cfr_reference: "21 CFR 882.5800"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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

(b)Classification. Class III (premarket approval).

(c)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.

§882.5800 - Cranial electrotherapy stimulator.