dermaPACE Console
Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Hebei (3), Beijing (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 2 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
Record
| Listed by | Sanuwave, Inc., United States |
|---|---|
| FDA product code | PZL |
| Device type | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4685 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | DEN160037 |
| Record published | 2021-01-25 |
| Record revised | 2025-09-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DEP0330 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dermagold100 | MTS Medical AG | 2 |
| dermaPACE Applicator | Sanuwave, Inc. | 1 |
| CS-Pro MED | Curative Sound, LLC | 1 |
| dermaPACE System (Console with applicator) | Sanuwave, Inc. | 1 |
| Softwave Gold Li | MTS Medical AG | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| DEN160037 | 2017-12-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.