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U.S. Department of Health and Human Services

Product Classification
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Device aid, visual, for nausea
Definition To relieve the symptoms associated with motion sickness.
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
Product CodeOAA
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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