# K162797: SpringTMS

- Pathway: 510(k) (Traditional)
- Applicant: Eneura, Inc.
- Decided: Jun 26, 2017 after 265 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: 2 generations back to DEN130022 (2013). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140094: Springtms Total Migraine System, Eneura Therapeutics, LLC (2014) Summary page 5.

## Most influential descendants
- K182976: SpringTMS (2019), 1 descendant of its own
- K230358: SAVI Dual (TM) Migraine Therapy (2023), 0 descendants of its own

## Indications for use
The eNeura Inc. SpringTMS® is indicated for the acute and prophylactic treatment of migraine headache.

Source page: https://510kreport.com/device/K162797
Methodology: https://510kreport.com/methodology