The DOC Band^® is a Class II Cranial Orthosis cleared by the FDA for treatment of plagiocephaly. Federal law restricts this device to sale by or on the order of a physician.

Indications for Use: The DOC Band^® is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic-shaped heads. The device is intended to apply pressure to the prominent regions of an infant's cranium, to improve cranial symmetry and/or shape.

Contraindications: The DOC Band^® is contraindicated for synotosis and hydrocephalus.

Adverse Events: Skin irritation and breakdown occurs in less than 5% of children treated. Specific treatment protocols have been established to address skin issues should they occur.

Here are CranialTech's clearances:

• K964992
• K014012
• K042385

COM-001, Rev 02, ECO 12-068 - Effective 04/30/2012