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 | ||
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Manufacturer | Decision | |
SANUWAVE, INC. | ||
GRANTED | 1 |