# K230358: SAVI Dual (TM) Migraine Therapy

- Pathway: 510(k) (Special)
- Applicant: Eneura, Inc.
- Decided: May 16, 2023 after 95 days
- Product code: OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache)
- Device class: 2
- Regulation: 21 CFR 882.5808
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN130022 (2013). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182976: SpringTMS, Eneura®, Inc. (2019) Summary page 4.

## Indications for use
The SAVI Dual™ Migraine Therapy device is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.

Source page: https://510kreport.com/device/K230358
Methodology: https://510kreport.com/methodology