Data / Medical devices / Israel / Theranica Bio-Electronics Ltd.
Theranica Bio-Electronics Ltd.: FDA-registered device maker in Caesarea Central, Israel, 3 510(k) clearances
Theranica Bio-Electronics Ltd. is registered with the FDA (registration 3015379717) in Caesarea Central, Israel. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 14, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015379717
- Address
- 9 Granit st., North Industrial Park, Caesarea Central, Israel, 3079893
- Owner or operator
- Theranica Bio-Electronics LTD. (10060818)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 27, 2019
- Registered through
- 2027
- Brand names listed
- Nerivio, Nerivio / Neerivio Infinity, Nerivio / Nerivio Infinity, Nerivio Infinity, NerivioInfinity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | QGT | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler | 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 14, 2025 | K250405 | Nerivio; Nerivio Infinity | QGT | Substantially Equivalent | Theranica Bio-Electronics, Ltd. | accessdata.fda.gov |
| November 8, 2023 | K232152 | NerivioInfinity | QGT | Substantially Equivalent | Theranica Bioelectronics , Ltd. | accessdata.fda.gov |
| May 20, 2019 | DEN180059 | Nerivio Migra | QGT | Unknown | Theranica Bioelectronics , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 23, 2026 | 99307 | Class II | Ongoing | Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 | Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. | accessdata.fda.gov |
Updated July 31, 2026. 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.