DermaGold100® OW100-US
DermaGold100 OW100-US (1000014) is a medical device (FDA Class II; FDA product code PZL, Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers) made by MTS Medical AG, cleared under FDA 510(k) K200926 on 28 Aug 2020 (1 earlier submission) and listed in FDA GUDID since 31 Mar 2020 (UDI-DI 04260484571649), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200926 | Date28 Aug 2020 | StatusActive |
| United States | GUDID listing | Number04260484571649 | Date31 Mar 2020 | StatusListed |
Official records
- AccessGUDID record 04260484571649
- FDA 510(k) database K200926
- FDA 510(k) database K191961
Across registries
- FDA 510(k) K200926 decided 28 Aug 2020 Active
- FDA GUDID UDI-DI 04260484571649 listed 31 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K191961
- Listed FDA GUDID 04260484571649
- Cleared FDA 510(k) K200926
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DermaGold100®
- Generic name
- Dermatological extracorporeal shock wave therapy system
- Model / Ref / Catalog
- OW100-US, 1000014
- Primary DI / UDI-DI
- 04260484571649
- 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
- Size
- Weight — 18 KilogramDepth — 459 MillimeterWidth — 400 MillimeterHeight — 218 Millimeter
Similar devices
Other devices filed under FDA product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers).