Tiac 1 M116E1
by El.en. SpA
Tiac 1 M116E1 is a microwave hyperthermia system applicator (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by El.en. SpA, cleared under FDA 510(k) K183371 on 3 Dec 2019 and listed in FDA GUDID since 19 Oct 2021 (UDI-DI 08057017760405), 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 | Number08057017760405 | Date19 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183371 | Date3 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 08057017760405
- FDA 510(k) database K183371
Across registries
- FDA 510(k) K183371 decided 3 Dec 2019 Active
- FDA GUDID UDI-DI 08057017760405 listed 19 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K183371
- Listed FDA GUDID 08057017760405
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tiac 1
- Generic name
- Microwave hyperthermia system applicator, extracorporeal
- Model / Ref / Catalog
- M116E1
- Primary DI / UDI-DI
- 08057017760405
- 510(k) Number
- FDA product code
- PBX
- GMDN term
- Microwave hyperthermia system applicator, extracorporeal
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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