Nerivio; Nerivio Infinity
FDA 510(k) clearance K250405 · decided 2025-05-14
Clearance details
- K-number
- K250405
- Device name
- Nerivio; Nerivio Infinity
- Applicant
- Theranica Bio-Electronics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-13
- Decision date
- 2025-05-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QGT
- Device class
- 2
- Regulation number
- 882.5899
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nerivio; NerivioInfinity (K241756) | Theranica Bio-Electronics, Ltd. | 2024-10-08 |
| NerivioInfinity (K232152) | Theranica Bioelectronics , Ltd. | 2023-11-08 |
| Nerivio (K223169) | Theranica Bioelectronics , Ltd. | 2023-02-06 |
| Nerivio, FGD000075-4.7 (K203181) | Theranica Bioelectronics , Ltd. | 2021-01-22 |
| Nerivio (K201824) | Theranica Bio-Electronics, Ltd. | 2020-10-23 |
| Nerivio Migra (DEN180059) | Theranica Bioelectronics , Ltd. | 2019-05-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, A recall (Z-2855-2026) | THERANICA BIOELECTRONICS LTD | 2026-07-31 |