{"data":{"id":"us/21-cfr-882.5970","jurisdiction":"us","citation":"21 CFR 882.5970","heading":"Cranial orthosis.","body":"(a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.\n(b) Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 882—NEUROLOGICAL DEVICES","Subpart F—Neurological Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"a53dc321f4256ae088dd0a892441c572c601dfc3a2b2faf220b0d76d1efdb88a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.5960","next":"us/21-cfr-884.1"},"notice":"GroundRules: Original legal text. Not legal advice."}