PZL

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Product code: PZL
Device name: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device class: Class 2
21 CFR: 21 CFR 878.4685
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 8

FDA classification definition

Treatment of diabetic foot ulcers

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Last three years. Most recent: 2025-08-13.

Number	Decision date	Applicant	Device name	Summary
K243279	2025-08-13	E.M.S Electro Medical Systems S.A	DOLORCLAST Focused Shock Waves	PDF
K250779	2025-07-02	Curative Sound Therapeutics	CS-Pro MED	PDF
K233937	2024-07-09	Softwave/Trt, LLC	OW100S	FDA

2 summaries are archived here for direct download.

Official FDA classification page: PZL

Classification and pathway per current FDA publications. Data from openFDA (CC0).