Dynamic Orthotic Cranioplasty Band; Doc Band
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN980001 FDA 510(k)
- FDA Product Code
- MVA FDA 510(k)
- Models / Variants
- Dynamic Orthotic Cranioplasty Band FDA 510(k)Doc Band FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5970 FDA 510(k)
- Regulation Number
- 882.5970 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Dynamic Orthotic Cranioplasty Band, also known as the Doc Band, is an orthosis, cranial, used for treatment of plagiocephaly. It is a custom-made cranial helmet. The device is used on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly.
The Doc Band is supplied as a single-use device and is intended for use in neurology. It has been cleared under FDA 510k, with the clearance type being Post-NSE, and has a device class of 2. The device is available in various sizes to accommodate different head shapes, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Frequently asked questions
What is the Dynamic Orthotic Cranioplasty Band (Doc Band) used for?
The Doc Band is used to treat moderate to severe non-synostotic positional plagiocephaly in infants from three to eighteen months of age by applying gentle, corrective pressure to reshape the skull as it grows.
How is the Doc Band supplied and is it reusable?
The Doc Band is supplied as a single-use, custom-made cranial helmet designed for one patient only; it is not intended for reuse due to its personalized fit and hygiene considerations.
What sizes or head shapes does the Doc Band accommodate?
The Doc Band is available in various sizes to fit different head shapes, including plagiocephalic, brachycephalic, and scaphocephalic configurations, allowing customization based on the infant’s specific cranial asymmetry.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DOC Band® Treatment for Plagiocephaly | Cranial Technologies, DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND (DEN980001) — FDA 510 (k ..., About Us | Cranial Technologies, DOC Band® Cranial Technologies Nationwide Clinic Locator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN980001 | Class II | Active |
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Manufacturer
- Manufacturer
- Cranial Technologies, Inc.
Sources (1)
- FDA 510(k) DEN980001 24 fields · synced Oct 6, 2026