Data / Medical devices / United States / Theranica Usa
Theranica Usa: FDA-registered device maker in Bridgewater, NJ, United States, 1 510(k) clearance
Theranica Usa is registered with the FDA (registration 3015549449) in Bridgewater, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015549449
- Address
- 100 Somerset Corporate Blvd 2nd Fl, Ste 160, Bridgewater, NJ, United States, 08807
- Owner or operator
- Theranica USA (10060939)
- Roles
- Repackager or relabeler
- First device listed
- May 5, 2026
- Registered through
- 2026
- Brand names listed
- Nerivio, Nerivio Infinity, Nerivio Infinity refill unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | QGT | 2 | 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 |
Updated May 14, 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.