Dermagold100 OW100S-US
Dermagold100 OW100S-US (1000022) 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) K231710 on 1 Sep 2023 and listed in FDA GUDID since 11 Sep 2023 (UDI-DI 04260484571823), 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 | GUDID listing | Number04260484571823 | Date11 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231710 | Date1 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 04260484571823
- FDA 510(k) database K231710
Across registries
- FDA 510(k) K231710 decided 1 Sep 2023 Active
- FDA GUDID UDI-DI 04260484571823 listed 11 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K231710
- Listed FDA GUDID 04260484571823
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- Withdrawn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
- OW100S-US, 1000022
- Primary DI / UDI-DI
- 04260484571823
- 510(k) 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
- Size
- Weight — 21 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).