Definition: To Relieve The Symptoms Associated With Motion Sickness.
Device Type ID | 1664 |
Device Name | Aid, Visual, For Nausea |
Physical State | Camera, Monitor, Transparency |
Technical Method | A Camera And Monitor Or Transparency Are Configured In Such A Manner So That The Motion In The Image As Perceived By The Passenger When The Vehicle Moves Matches The Motion Felt By That Passenger. |
Target Area | Auditory Vestibule |
Review Panel | Ear Nose & Throat |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
Submission Type | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | OAA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1664 |
Device | Aid, Visual, For Nausea |
Product Code | OAA |