Class Class II
Nerivio (K223169)
Description
Nerivio by Theranica Bioelectronics , Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223169
Clearance Date2023-02-06
Clearance TypeTraditional
Product CodeQGT
Regulation Number882.5899
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223169
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nerivio (K223169) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics , Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. | 2024 |
| K232152 | NerivioInfinity | Theranica Bioelectronics , Ltd. | 2023 |
Trace the full predicate network for K223169
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.