Identity
- Trade Name
- dermaPACE Console FDA UDI
- Generic Name
- Dermatological extracorporeal shock wave therapy system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DEP0330 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812265010218 FDA UDI
- 510(k) Number
- DEN160037 FDA UDI
- FDA Product Code
- PZL FDA UDI
- GMDN Term
- Dermatological extracorporeal shock wave therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4685 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological extracorporeal shock wave therapy system
dermaPACE Console by SANUWAVE Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological extracorporeal shock wave therapy system.
- DermaGold100® — MTS Medical AG · Class II
- Softwave Gold Li — MTS Medical AG · Class II
- Dermagold100 — MTS Medical AG · Class II
- dermaPACE System (Console with applicator) — SANUWAVE Health, Inc. · Class II
Cleared under the same submission
DEN160037 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SANUWAVE Health, Inc.
Sources (1)
- FDA UDI c201d920-1f57-4d79-b486-a533c5cdf2de 35 fields · synced May 30, 2026