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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 Code OAN
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
ReportingEligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Third Party Review
Not Third Party Eligible
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