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The DOC Band is indicated for use on infants from three to eighteen months of age with moderate to severe nonsynostotic cranial deformation, infants with plagiocephalic-, and scaphocephalic-, and scaphocephalic-shaped heads, or a combination thereof. The DOC Band 3D is also indicated for adjunctive use for infants from three to eighten months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-. brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof.

The DOC Band 3D is a cranial orthosis intended to treat positional plagiocephaly in infants from 3 to 18 months of age. The band is intended to apply a mild pressure to the prominent regions of an infant's cranium and to improve cranial symmetry, proportion, and/or shape.

This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.

This device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The DOC Band is a cranial orthosis used to treat positional or deformational plagiocephaly in infants from 3 to 18 months of age. The devices works by applying a gentle holding pressure to the prominent regions of an infants' skull while leaving room for growth in the adjacent flattened regions. The orthosis is made from a three-dimensional (3D) digital model of an infants' cranium acquired with the C3D - Cranial Imaging System™. This system was developed to capture an accurate, 3D image of an infants' head shape. It is based upon the well-established field of photogrammetry, and utilizes structured light and triangulated CCD cameras to digitally reproduce the 3D model. The system uses a noncoherent (i.e. non-laser light) light source, and captures a complete 3D image of the infants' head-shape, including the face and top of the head, in 1/180th of a second with an accuracy of +/- 0.5 mm. During acquisition, a 3D photograph of the child is also captured and precisely laid over the model for confirmation of the patient's identity. The digital model is then sent electronically to Cranial Technologies who creates a positive model using computer aided machining software and a 5-axis CNC mill. The positive model is then used to create the DOC Band, which is fit clinically and monitored as described in K-964992.