§ 882.5970. Cranial orthosis.
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/us/cfr/t21/s§ 882.5970·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 882.5970
Cranial orthosis.
Fed. Reg.×3
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