510(k) K250405 ยท QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Nerivio; Nerivio Infinity
| Applicant | Theranica Bio-Electronics, Ltd., Netanya, IL |
| Decision | Substantially Equivalent, May 14, 2025 |
| Received | Feb 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | THERANICA BIOELECTRONICS LTD Nerivio Infinity. Model/Catalog Number: FGD000100.
Software Version: FW Version 4.1.2.0, App version 7.28.0.11 Open, Classified |
QGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.