Data / Medical devices / Austria / Thi Total Healthcare Innovation GMBH
Thi Total Healthcare Innovation GMBH: FDA-registered device maker in Feistritz im Rosental Karnten, Austria, 2 510(k) clearances
Thi Total Healthcare Innovation GMBH is registered with the FDA (registration 3017300722) in Feistritz im Rosental Karnten, Austria. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017300722
- Address
- Gewerbestrasse 4, Feistritz im Rosental Karnten, Austria, 9181
- Owner or operator
- THI Total Healthcare Innovation GmbH (10089072)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 3, 2023
- Registered through
- 2026
- Brand names listed
- ViVi Helmet, ViVi Helmet HPL, ViVi Helmet25, ViVi Helmet25 HPL, ViVi Helmet25XL, ViVi Helmet25XL HPL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gown, Surgical | FYA | 2 | Specification developer | accessdata.fda.gov |
| Helmet, Surgical | FXZ | 1 | Manufacturer | accessdata.fda.gov |
| Hood, Surgical | FXY | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2025 | K243522 | ViVi® Toga Premium | FYA | Substantially Equivalent | Thi Total Healthcare Innovation GmbH | accessdata.fda.gov |
| October 17, 2023 | K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | FXY | Substantially Equivalent | Thi Total Healthcare Innovation GmbH | accessdata.fda.gov |
Compare with other makers
Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.