OKP · Class II · 21 CFR 882.5808

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..

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
1–6 of 6
Cleared May 16, 2023
SAVI Dual (TM) Migraine Therapy
K230358
Eneura, Inc.
Neurology · 95d
Cleared Feb 25, 2019
SpringTMS
K182976
Eneura, Inc.
Neurology · 122d

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.