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U.S. Department of Health and Human Services

Product Classification

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Device extracorporeal shock wave device for treatment of diabetic foot ulcers
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 CodePZL
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible