Class Class II
SAVI Dual (TM) Migraine Therapy (K230358)
Description
SAVI Dual (TM) Migraine Therapy by Eneura, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230358
Clearance Date2023-05-16
Clearance TypeSpecial
Product CodeOKP
Regulation Number882.5808
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230358
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. SAVI Dual (TM) Migraine Therapy (K230358) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182976 | SpringTMS | Eneura®, Inc. | 2019 |
| K161663 | sTMS mini | Eneura, Inc. | 2016 |
Trace the full predicate network for K230358
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.