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U.S. Department of Health and Human Services

Product Classification

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Device electronic media, nausea
Definition Treatment of nausea and vomiting associated with morning sickness and motion sickness.
Review Panel General & Plastic Surgery
Product CodeNSS
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible