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; Fo
| Device Type ID | 1421 |
| Device Name | Mouthguard, Migraine/tension Headache |
| Physical State | Plastic Mouthguard Fitted To The Teeth |
| Technical Method | Mouthguard Repositions The Jaw To Reduce Muscle Tension |
| Target Area | Oral Cavity |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OCO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1421 |
| Device | Mouthguard, Migraine/tension Headache |
| Product Code | OCO |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LUCO HYBRID OSA APPLIANCE INC, | ||
SUBSTANTIALLY EQUIVALENT | 1 | |