| Device |
transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms |
| Definition |
A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s head. The device is not intended as a stand-alone therapy or to alter usual care treatment. |
| Physical State |
A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms may consist of an enclosure for a printed circuit board assembly (PCBA), embedded software managing device functionality, and electrode pads or leads for delivering the stimulation to the patient's head. |
| Technical Method |
A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms is to be used externally on the head to generate and deliver electrical stimulation for regulating stress response, emotional processing, and circadian rhythm in patients with PTSD. |
| Target Area |
Neural pathways of the brain responsible for regulating stress response, emotional processing, and circadian rhythm. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SHX |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5807
|
|---|
| 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 |
