PZL — Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers Class II
Classification Details
- Product Code
- PZL
- Device Class
- Class II
- Regulation Number
- 878.4685
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Treatment of diabetic foot ulcers
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243279 | e.m.s electro medical systems | DOLORCLAST Focused Shock Waves | August 13, 2025 |
| K250779 | curative sound therapeutics | CS-Pro MED | July 2, 2025 |
| K233937 | softwave/trt | OW100S | July 9, 2024 |
| K231710 | softwave/trt | OW100S | September 1, 2023 |
| K202112 | storz medical | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | February 21, 2021 |
| K200926 | tissue regeneration technologies | OrthoGold 100 | August 28, 2020 |
| K191961 | tissue regeneration technologies | OrthoGold | November 26, 2019 |
| DEN160037 | sanuwave | dermaPACE System | December 28, 2017 |