| Device |
electronic media, nausea |
| Definition |
Treatment of nausea and vomiting associated with morning sickness and motion sickness. |
| Review Panel |
General & Plastic Surgery |
| Product Code | NSS |
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
|
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 |
|
|