| 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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
