# K161663: sTMS mini

- Pathway: 510(k) (Special)
- Applicant: Eneura, Inc.
- Decided: Aug 23, 2016 after 68 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.
No later device cites it as a predicate yet.
0 of 3 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 4.

## Indications for use
The eNeura® sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura.

Source page: https://510kreport.com/device/K161663
Methodology: https://510kreport.com/methodology