Nerivio Migra
FDA 510(k) clearance DEN180059 · decided 2019-05-20
Clearance details
- K-number
- DEN180059
- Device name
- Nerivio Migra
- Applicant
- Theranica Bioelectronics , Ltd.
- Decision
- Unknown
- Date received
- 2018-11-06
- Decision date
- 2019-05-20
- Days to decision
- 195 days
- Clearance type
- Direct
- 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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| Nerivio; Nerivio Infinity (K250405) | Theranica Bio-Electronics, Ltd. | 2025-05-14 |
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| Nerivio (K201824) | Theranica Bio-Electronics, Ltd. | 2020-10-23 |
Recalls involving this device
No recalls on record reference this clearance.