Company ยท IL
Theranica Bioelectronics , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 8, 2023 | K232152 | NerivioInfinity Theranica Bioelectronics , Ltd., IL | QGT |
| Feb 6, 2023 | K223169 | Nerivio Theranica Bioelectronics , Ltd., IL | QGT |
| Jan 22, 2021 | K203181 | Nerivio, FGD000075-4.7 Theranica Bioelectronics , Ltd., IL | QGT |
| May 20, 2019 | DEN180059 | Nerivio Migra Theranica Bioelectronics , Ltd., IL | QGT |
Latest recalls
| 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 | K250405 |