Device |
device, electroconvulsive therapy |
Regulation Description |
Electroconvulsive therapy device. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | GXC |
Premarket Review |
Neuromodulation and Physical Medicine Devices
(DHT5B)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
PMA
|
Regulation Number |
882.5940
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|