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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, cranial, laser scan
Regulation Description Cranial orthosis.
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.
Product CodeOAN
Regulation Number 882.5970
Device Class 2

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