---
kind: "section"
citation: "21 C.F.R. § 882.5970"
title: "21"
number: "882.5970"
heading: "Cranial orthosis."
url: "https://uscodex.org/cfr/21/882.5970"
---

# §882.5970. Cranial orthosis.

- (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](/cfr/21/801.109.md) of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).

## Notes

### Amendments

[63 FR 40651, July 30, 1998]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[63 FR 40651, July 30, 1998]