FDA Product Code OKP: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
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.
Leading manufacturers include Eneura, Inc., Eneura Therapeutics and Eneura Therapeutics, LLC.
6
Total
5
Cleared
160d
Avg days
2013
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache Devices (Product Code OKP)
6 devices
Cleared
May 16, 2023
SAVI Dual (TM) Migraine Therapy
Eneura, Inc.
Neurology
95d
Cleared
Feb 25, 2019
SpringTMS
Eneura, Inc.
Neurology
122d
Cleared
Jun 26, 2017
SpringTMS
Eneura, Inc.
Neurology
265d
Cleared
Aug 23, 2016
sTMS mini
Eneura, Inc.
Neurology
68d
Cleared
May 21, 2014
SPRINGTMS TOTAL MIGRAINE SYSTEM
Eneura Therapeutics, LLC
Neurology
127d
Not Cleared
Dec 13, 2013
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
Eneura Therapeutics
Neurology
283d
About Product Code OKP - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code OKP since 2013, with 5 receiving FDA clearance (average review time: 160 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.