21 C.F.R. § 882.5970 Cranial orthosis.
Title 21 - Food and Drugs
(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. (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)). [63 FR 40651, July 30, 1998]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§ 882.5970 Cranial orthosis.
