DeviceClearance

Product code OCO— Unknown

NTI TENSION SUPPRESSION SYSTEM

Classification name
Mouthguard, Migraine/Tension Headache
Device class
Unclassified
Advisory panel
Unknown
Total cleared
3
First cleared
Most recent

FDA classification definition

“A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity.”

— U.S. Food and Drug Administration, device classification record for product code OCO, via openFDA

Market context for product code OCO

FDA has cleared 3 devices under product code OCO between 2001 and 2021, filed by 3 applicant companies. No FDA device recalls reference this product code.

Clearances per year

Top applicants under product code OCO

Recent clearances under product code OCO

Data sourced from openFDA. This site is unofficial and independent of the FDA.