Definition: Treatment Of Diabetic Foot Ulcers
| Device Type ID | 5903 |
| Device Name | Extracorporeal Shock Wave Device For 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 S |
| Target Area | The Device Generally Targets Foot Skin Including The Dermis, The Epidermis, And Underlying Soft Tissue. |
| Regulation Description | Extracorporeal Shock Wave Device For Treatment Of Chronic Wounds. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4685 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5903 |
| Device | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Product Code | PZL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extracorporeal Shock Wave Device For Treatment Of Chronic Wounds. |
| CFR Regulation Number | 878.4685 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SANUWAVE, INC. | ||
GRANTED | 1 | |