FDA product code PZL: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
PZL is the FDA product code for extracorporeal shock wave device for treatment of diabetic foot ulcers. It is a Class II device, regulated under 21 CFR 878.4685 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under PZL, 4 in the last five years, from 6 different applicants. The average 510(k) review took 168 days (median 143); 207 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Treatment of diabetic foot ulcers
Classification
| Field | Value |
|---|---|
| Device name | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Device class | Class II |
| Regulation | 21 CFR 878.4685 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 126 |
| 2020 | 1 | 143 |
| 2021 | 1 | 206 |
| 2023 | 1 | 81 |
| 2024 | 1 | 208 |
| 2025 | 2 | 206 |
Compare with all 510(k) review times · Search every PZL clearance
Top PZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Softwave/Trt, LLC | 2 | 2024-07-09 |
| E.M.S Electro Medical Systems S.A | 1 | 2025-08-13 |
| Curative Sound Therapeutics | 1 | 2025-07-02 |
| Storz Medical AG | 1 | 2021-02-21 |
| Tissue Regeneration Technologies, LLC | 1 | 2020-08-28 |
1 more applicants have PZL clearances. See the full list in Caduvo.
Most recent PZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243279 | E.M.S Electro Medical Systems S.A | DOLORCLAST Focused Shock Waves | 2025-08-13 | 301 |
| K250779 | Curative Sound Therapeutics | CS-Pro MED | 2025-07-02 | 110 |
| K233937 | Softwave/Trt, LLC | OW100S | 2024-07-09 | 208 |
| K231710 | Softwave/Trt, LLC | OW100S | 2023-09-01 | 81 |
| K202112 | Storz Medical AG | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | 2021-02-21 | 206 |
Recalls for PZL devices
openFDA lists no recalls for product code PZL.
Frequently asked questions
What is FDA product code PZL?
PZL is the FDA product code for extracorporeal shock wave device for treatment of diabetic foot ulcers. It is a Class II device, regulated under 21 CFR 878.4685 and reviewed by the General and Plastic Surgery panel.
What device class is PZL?
Class II, regulation 21 CFR 878.4685. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZL?
Across 7 cleared submissions the average was 168 days from receipt to decision (median 143).
Which companies have the most PZL clearances?
Softwave/Trt, LLC (2); E.M.S Electro Medical Systems S.A (1); Curative Sound Therapeutics (1); Storz Medical AG (1); Tissue Regeneration Technologies, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZL
- Run a recall and safety report across every PZL manufacturer
- Watch product code PZL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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