← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PZL — Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Treatment of diabetic foot ulcers
DEVICE CLASS
Class II
REGULATION
21 CFR 878.4685
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K243279E.M.S Electro Medical Systems S.A · 510k2025-08-13
K250779Curative Sound Therapeutics · 510k2025-07-02
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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