OKPClass II
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Neurology · 21 CFR 882.5808
Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.
MDR events3All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances6All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Injury3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Eneura, Inc.May 16, 2023
K230358 · SAVI Dual (TM) Migraine Therapy
- Eneura®, Inc.Feb 25, 2019
K182976 · SpringTMS
- Eneura, Inc.Jun 26, 2017
K162797 · SpringTMS
- Eneura, Inc.Aug 23, 2016
K161663 · sTMS mini
- Eneura Therapeutics, LLCMay 21, 2014
K140094 · SPRINGTMS TOTAL MIGRAINE SYSTEM
- Eneura TherapeuticsDec 13, 2013
DEN130022 · NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR