dermaPACE Applicator
Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
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 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DAP0332 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dermagold100 | MTS Medical AG | 2 |
| CS-Pro MED | Curative Sound, LLC | 1 |
| dermaPACE System (Console with applicator) | Sanuwave, Inc. | 1 |
| dermaPACE Console | 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.