| Device |
piezo-electric stimulator for relief of mosquito bite itch |
| Regulation Description |
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. |
| Definition |
Relief / Reduction of Mosquito Bite Itch |
| Physical State |
The device is hand-held, composed of an insulated housing which contains a piezo-electric crystal and conductive elements to deliver charge to the skin, as well as a moving mechanical part to allow the intended user to generate the force to produce the electrical charge. |
| Technical Method |
Electrical charge, generated via piezo-electric crystal, delivered transcutaneously at the site of the mosquito bite. The piezo-electric crystal generates electrical charge by the application of a manual mechanical force. |
| Target Area |
Intended to be placed on the skin, at the site of a mosquito bite. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OSG |
|---|
| Premarket Review |
Neuromodulation and Rehabilitation Devices
(DHT5B)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
882.5894
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
