PZL
8 FDA 510(k) clearances · Product code
206 daysmedian time to decision
521 days90th percentile
8clearances measured
FDA profile
- Official device name
- Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4685
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Treatment of diabetic foot ulcers
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DOLORCLAST Focused Shock Waves (K243279) | E.M.S Electro Medical Systems S.A | 2025-08-13 |
| CS-Pro MED (K250779) | Curative Sound Therapeutics | 2025-07-02 |
| OW100S (K233937) | Softwave/Trt, LLC | 2024-07-09 |
| OW100S (K231710) | Softwave/Trt, LLC | 2023-09-01 |
| Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (K202112) | Storz Medical AG | 2021-02-21 |
| OrthoGold 100 (K200926) | Tissue Regeneration Technologies, LLC | 2020-08-28 |
| OrthoGold (K191961) | Tissue Regeneration Technologies | 2019-11-26 |
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |
Track PZL automatically
Every clearance here is in the API, with alerts when new ones post.