Data / Medical devices / Israel / Initia, Ltd.
Initia, Ltd.: FDA-registered device maker in Petah Tikva Central, Israel, 3 510(k) clearances
Initia, Ltd. is registered with the FDA (registration 3017140415) in Petah Tikva Central, Israel. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 1, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017140415
- Address
- 10 Nevatim Str., Petah Tikva Central, Israel, 4956106
- Owner or operator
- Initia, Ltd. (10075838)
- Roles
- Manufacturer
- First device listed
- June 28, 2020
- Registered through
- 2026
- Brand names listed
- Integra, Integra SL, Magna, MoreNova DT (10-MRNV-000), MoreNova PRO (10-MPRB-000)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 1, 2012 | K111947 | DUET MAGNA | LNS | Substantially Equivalent | Direx Systems Corp. | accessdata.fda.gov |
| October 20, 2006 | K062147 | INTEGRA SL | LNS | Substantially Equivalent | Direx Systems Corp. | accessdata.fda.gov |
| March 1, 2006 | K053640 | INTEGRA | LNS | Substantially Equivalent | Direx Systems Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
- All makers of Massager, Therapeutic, Electric
Updated March 1, 2012. 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.