Data / Medical devices / Italy / I-Tech Industries SRL
I-Tech Industries SRL: FDA-registered device maker in Bologna, Italy, 2 510(k) clearances
I-Tech Industries SRL is registered with the FDA (registration 3013517454) in Bologna, Italy. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 22, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013517454
- Address
- Via I Maggio 4/Q Granarolo dell'Emilia, Bologna, Italy, 40057
- Owner or operator
- I-Tech Industries srl (10054745)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 21, 2017
- Registered through
- 2027
- Brand names listed
- B-MOOVE, ICOONE, ICOONE BEAUTY, ICOONE BOOSTER, ICOONE H (Also Referred To As ICOONE LASER And ICOONE H LASER), ICOONE H (also referred to as ICOONE Medical), ICOONE M, IMOOVE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Powered | BXB | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 22, 2021 | K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | NUV | Substantially Equivalent | I-Tech Industries Srl | accessdata.fda.gov |
| January 11, 2019 | K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | NUV | Substantially Equivalent | I-Tech Industries Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Light Induced Heating
- All makers of Massager, Therapeutic, Electric
- All makers of Exerciser, Powered
Updated June 22, 2021. 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.