510(k) K010876
K010876 is an FDA 510(k) premarket notification submitted by Nti-Tss, Inc. for the device "NTI TENSION SUPPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2001. The device falls under product code OCO (Mouthguard, Migraine/Tension Headache), a Class U device. Nti-Tss, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2001
- Date Received
- March 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Migraine/Tension Headache
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type
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.