# DEN130022: Neuralieve Cerena Transcranial Magnetic Stimulator

- Pathway: De Novo (Direct)
- Applicant: Eneura Therapeutics
- Decided: Dec 13, 2013 after 283 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K140094: Springtms Total Migraine System (2014), 4 descendants of its own
- K162797: SpringTMS (2017), 2 descendants of its own
- K182976: SpringTMS (2019), 1 descendant of its own
- K230358: SAVI Dual (TM) Migraine Therapy (2023), 0 descendants of its own
- K161663: sTMS mini (2016), 0 descendants of its own

## Indications for use
indicated for the acute treatment of pain associated with migraine headache with aura

Source page: https://510kreport.com/device/DEN130022
Methodology: https://510kreport.com/methodology