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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Cranial orthotics are custom-made for each patient's head. They are typically made from plastics, foam and velcro.
Technical Method A mold is made of the baby's head to create the orthotic. Plaster or laser scanning may be used to create the mold.
Target Area Infant craniums
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOAN
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5970
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible