PZL · Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
General, Plastic Surgery · 21 CFR 878.4685 · Class 2
Overview
| Product Code | PZL |
|---|---|
| Device Name | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Regulation | 21 CFR 878.4685 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use. (4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life. (7) Physician labeling must include: (i) Information on how the device operates and the typical course of treatment; (ii) A detailed summary of the device's technical parameters; (iii) Validated methods and instructions for reprocessing of any reusable components; and (iv) Instructions for preventing hearing loss by use of hearing protection. (8) Patient labeling must include: (i) Relevant contraindications, warnings, precautions, adverse effects, and complications; (ii) Information on how the device operates and the typical course of treatment; (iii) The probable risks and benefits associated with the use of the device; (iv) Post-procedure care instructions; and (v) Alternative treatments.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | Aug 13, 2025 | SESE |
| K250779 | CS-Pro MED | Curative Sound Therapeutics | Jul 2, 2025 | SESE |
| K233937 | OW100S | Softwave/Trt, LLC | Jul 9, 2024 | SESE |
| K231710 | OW100S | Softwave/Trt, LLC | Sep 1, 2023 | SESE |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | Feb 21, 2021 | SESE |
| K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | Aug 28, 2020 | SESE |
| K191961 | OrthoGold | Tissue Regeneration Technologies | Nov 26, 2019 | SESE |
| DEN160037 | dermaPACE System | Sanuwave, Inc. | Dec 28, 2017 | DENG |
Top Applicants
- Softwave/Trt, LLC — 2 clearances
- Curative Sound Therapeutics — 1 clearance
- E.M.S Electro Medical Systems S.A — 1 clearance
- Sanuwave, Inc. — 1 clearance
- Storz Medical AG — 1 clearance
