dermaPACE Console DEP0330
dermaPACE Console DEP0330 is a medical device (FDA Class II; FDA product code PZL, Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers) made by SANUWAVE Health, Inc., granted FDA De Novo DEN160037 on 28 Dec 2017 and listed in FDA GUDID since 25 Jan 2021 (UDI-DI 00812265010218), active as of 22 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812265010218 | Date25 Jan 2021 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN160037 | Date28 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 00812265010218
- FDA De Novo database DEN160037
Across registries
- FDA De Novo DEN160037 decided 28 Dec 2017 Active
- FDA GUDID UDI-DI 00812265010218 listed 25 Jan 2021 Listed
Timeline
- Granted FDA De Novo DEN160037
- Listed FDA GUDID 00812265010218
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- dermaPACE Console
- Generic name
- Dermatological extracorporeal shock wave therapy system
- Model / reference
- DEP0330
- Primary DI / UDI-DI
- 00812265010218
- De Novo Number
- FDA product code
- PZL
- GMDN term
- Dermatological extracorporeal shock wave therapy system
- Device class
- Class II
- Regulation number
- 878.4685
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers).