The DOC Band^® received FDA approval in 1998 and was the first device cleared by the US Food and Drug Administration for treatment of plagiocephaly. To date, it is the only device with clinical studies demonstrating safety and effectiveness.

The Federal Register Volume 63, No. 146 published the FDA approval in full detail on July 30, 1998.
Read FDA Approval

The DOC Band^® is a Class II Cranial Orthosis approved 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.

Close Window

Careers | Regulatory Info | Privacy Policies | Site Map | Advertising Policy | Research

Disclaimer: The information contained in Cranial Technologies' website should not be used as a substitute for the medical advice of your physician. There may be variations in treatment that your physician may recommend based on individual facts and circumstances. If you have questions regarding treatment of an infant currently in the DOC Band®, clinicians at the center providing treatment should be contacted directly. For feedback or general questions about our website, please email the webmaster at wbmgr@cranialtech.com Website Last Revised: January 12 2007 Created: August 16 2002 ©1997-2007 Cranial Technologies Inc. All rights reserved. DOC, DOC Band and Dynamic Orthotic Cranioplasty are Trademarks of Cranial Technologies, Inc. U.S. Patents 5,094,229; 5,038,312; 5,951,503; 6,346,353. Site Design by Park&Co.