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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)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
8 (all years; only the last 3 years are listed here)

FDA classification definition

Treatment of diabetic foot ulcers

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

510(k) clearances, last 3 years (3)

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

NumberDecision dateApplicantDevice nameSummary
K2432792025-08-13E.M.S Electro Medical Systems S.ADOLORCLAST Focused Shock WavesPDF
K2507792025-07-02Curative Sound TherapeuticsCS-Pro MEDPDF
K2339372024-07-09Softwave/Trt, LLCOW100SFDA

2 summaries are archived here for direct download.

Official FDA classification page: PZL
Classification and pathway per current FDA publications. Data from openFDA (CC0).