NTI TENSION SUPPRESSION SYSTEM
Device Facts
| Record ID | K010876 |
|---|---|
| Device Name | NTI TENSION SUPPRESSION SYSTEM |
| Applicant | Nti-Tss, Inc. |
| Product Code | OCO · DE |
| Decision Date | Jun 20, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Regulatory Classification
Identification
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.
