Device |
stimulator, nerve, electrical, transcutaneous, for migraine |
Regulation Description |
Transcutaneous electrical nerve stimulator to treat headache. |
Definition |
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin. |
Physical State |
Electrical stimulation unit with leads and cutaneous electrodes. |
Technical Method |
Applies an electrical current through electrodes on patient's skin. |
Target Area |
Afferent cranial nerves. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | PCC |
Premarket Review |
Neuromodulation and Physical Medicine Devices
(DHT5B)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
882.5891
|
Device Class |
2
|
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 |