Device |
cranial electrotherapy stimulator to treat insomnia and/or anxiety |
Regulation Description |
Cranial electrotherapy stimulator. |
Definition |
To provide electrical current to the head to treat insomnia and/or anxiety |
Physical State |
Electrodes and an electrical stimulus generator |
Technical Method |
Electrodes placed on the head of the patient and electrical generator applies an electrical current trancutaneously to the head |
Target Area |
Cranial nerves |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | QJQ |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
882.5800
|
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 |