FDA 510(k) Premarket Notification #K010876  (FDA's Summary) of the NTI Tension Suppression System                                                                                                                                      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