Device |
transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms |
Definition |
Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms. |
Physical State |
Electrical stimulation unit with leads and cutaneous electrodes. |
Technical Method |
Applies an electrical current through electrodes on patient's skin. |
Target Area |
Sensory nerves |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | QSQ |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
882.5888
|
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 |