Extracorporeal Shock Wave Device for Treatment of Diabetic Foot Ulcers

What Is It?

Treatment of diabetic foot ulcers

How Is PZL Classified?

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers is FDA product code PZL, Class 2, 21 CFR 878.4685.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.