| Device |
distal transcutaneous electrical stimulator for treatment of acute migraine |
| Regulation Description |
Trunk and limb electrical stimulator to treat headache. |
| Definition |
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously. |
| Physical State |
Hardware with battery/electronics and electrodes residing in an band placed on an area other than the head. Bluetooth connection with a mobile application. |
| Technical Method |
External electrical stimulation to create a perceptive sensation (non-painful) |
| Target Area |
External (on the skin) of the limbs. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | QGT |
|---|
| Premarket Review |
Neuromodulation and Rehabilitation Devices
(DHT5B)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5899
|
|---|
| 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 |
