…continued from Page 4
Migraine Prevention: The NTI-tss device is the only FDA cleared non-drug, non-surgical method of migraine prevention.
FDA 510(k) Premarket Notification #K010876 (FDA’s Summary) of the NTI Tension Suppression System (Migraine Etiology Hypothesis, Device and protocol developed by James P. Boyd, DDS)
Indications for Use approved for marketing, June 21, 2001
Approved Indications for Use for the NTI Tension Suppression System (NTI-tss):
1. 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;
2. For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity