Nerivio, FGD000075-4.7
FDA 510(k) clearance K203181 · decided 2021-01-22
Clearance details
- K-number
- K203181
- Device name
- Nerivio, FGD000075-4.7
- Applicant
- Theranica Bioelectronics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-26
- Decision date
- 2021-01-22
- Days to decision
- 88 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; Nerivio Infinity (K250405) | Theranica Bio-Electronics, Ltd. | 2025-05-14 |
| 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 (K201824) | Theranica Bio-Electronics, Ltd. | 2020-10-23 |
| Nerivio Migra (DEN180059) | Theranica Bioelectronics , Ltd. | 2019-05-20 |
Recalls involving this device
No recalls on record reference this clearance.