Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Device Code: 5903

Product Code(s): PZL

Definition: Treatment Of Diabetic Foot Ulcers

Device Classification Information

Device Type ID5903
Device NameExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Physical StateThe 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 MethodThe 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 AreaThe Device Generally Targets Foot Skin Including The Dermis, The Epidermis, And Underlying Soft Tissue.
Regulation DescriptionExtracorporeal Shock Wave Device For Treatment Of Chronic Wounds.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(k)
CFR Regulation Number878.4685 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePZL
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5903
DeviceExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Product CodePZL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionExtracorporeal Shock Wave Device For Treatment Of Chronic Wounds.
CFR Regulation Number878.4685 [🔎]
Premarket Reviews
ManufacturerDecision
SANUWAVE, INC.
 
GRANTED
1
TPLC Last Update: 2019-04-02 21:14:12

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