| Device |
extracorporeal shock wave device for treatment of diabetic foot ulcers |
| Regulation Description |
Extracorporeal shock wave device for treatment of chronic wounds. |
| Definition |
Treatment of diabetic foot ulcers |
| Physical State |
The device generally has a console with a handheld applicator attachment. The device has touch tone/display screen or other mechanical buttons for user interactions. |
| Technical Method |
The shock waves can be generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the patient with a specially designed reflector, dish, or acoustic lens. The shock waves are created inside a liquid medium within the device, and are transferred to the patient's body using an appropriate acoustic interface. |
| Target Area |
The device generally targets foot skin including the dermis, the epidermis, and underlying soft tissue. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PZL |
|---|
| Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4685
|
|---|
| 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 |
