Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
The Extracorporeal Shock Wave Device for Treatment of Diabetic Foot Ulcers is a non-invasive device that uses extracorporeal shock waves applied externally to treat diabetic foot ulcers, promoting wound healing in patients with this complication of diabetes. It is classified as a Class 2 device under regulation 878.4685, requiring 510(k) premarket notification before marketing, and falls within the General, Plastic Surgery (SU) medical specialty. The product code is PZL. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZL
- Device Class
- FDA class 2
- Regulation Number
- 878.4685
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Treatment of diabetic foot ulcers
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock Waves | Aug 13, 2025 | Substantially Equivalent | E.M.S Electro Medical Systems S.A |
| K250779 | CS-Pro MED | Jul 02, 2025 | Substantially Equivalent | Curative Sound Therapeutics |
| K233937 | OW100S | Jul 09, 2024 | Substantially Equivalent | Softwave/Trt, LLC |
| K231710 | OW100S | Sep 01, 2023 | Substantially Equivalent | Softwave/Trt, LLC |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Feb 21, 2021 | Substantially Equivalent | Storz Medical AG |
| K200926 | OrthoGold 100 | Aug 28, 2020 | Substantially Equivalent | Tissue Regeneration Technologies, LLC |
| K191961 | OrthoGold | Nov 26, 2019 | Substantially Equivalent | Tissue Regeneration Technologies |
| DEN160037 | dermaPACE System | Dec 28, 2017 | Unknown | Sanuwave, Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.