Vcare Alpha Vcare α® Device
Vcare Alpha Vcare α® Device (VCA233e) is a Class II device made by I.V.T. Medical Ltd, cleared under FDA 510(k) K121817 on 17 Sep 2013 and listed in FDA GUDID since 13 Aug 2017 (UDI-DI 07290111490002), active as of 2 Nov 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 | Number07290111490002 | Date13 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121817 | Date17 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 07290111490002
- FDA 510(k) database K121817
Across registries
- FDA 510(k) K121817 decided 17 Sep 2013 Active
- FDA GUDID UDI-DI 07290111490002 listed 13 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K121817
- Listed FDA GUDID 07290111490002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vcare Alpha
- Generic name
- Negative-pressure wound therapy system, electric, reusable
- Model / Ref / Catalog
- Vcare α® Device, VCA233e
- Primary DI / UDI-DI
- 07290111490002
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy system, electric, reusable
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
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