OKPClass II

Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache

21 CFR 882.5808 / Neurology

OKP is the FDA product code for Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache, a class II device type, regulated under 21 CFR 882.5808. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 2023-05-16, and no recalls.

Classification record

Product code: OKP
Device name: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
FDA definition: 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.
Regulation: 21 CFR 882.5808
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 6
Ingested recalls: 0

Clearances, product code OKP

By decision year

6 clearances under product code OKP with a decision year between 2013 and 2023, 2013 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OKP by decision year
Year	Clearances
2013	1
2014	1
2016	1
2017	1
2019	1
2023	1

Applicants with the most clearances

Product code OKP

Applicants holding the most 510(k) clearances under product code OKP
Applicant	Clearances
eNeura Inc	4
Eneura Therapeutics	2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OKP

Recent recalls

Product code OKP

FDA records show no recalls under product code OKP.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)