OAN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5970
Classification
FDA Product Code
OAN
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5970
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.