FDA product code OKP: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
OKP is the FDA product code for transcranial magnetic stimulator for the treatment of migraine headache. It is a Class II device, regulated under 21 CFR 882.5808 and reviewed by the Neurology panel. FDA has cleared 5 510(k) submissions under OKP, 1 in the last five years, from 3 different applicants. The average 510(k) review took 135 days (median 122). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Device class | Class II |
| Regulation | 21 CFR 882.5808 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for OKP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2019 | 1 | 122 |
| 2023 | 1 | 95 |
Compare with all 510(k) review times · Search every OKP clearance
Top OKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eneura, Inc. | 3 | 2023-05-16 |
| Eneura®, Inc. | 1 | 2019-02-25 |
| Eneura Therapeutics, LLC | 1 | 2014-05-21 |
Most recent OKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230358 | Eneura, Inc. | SAVI Dual (TM) Migraine Therapy | 2023-05-16 | 95 |
| K182976 | Eneura®, Inc. | SpringTMS | 2019-02-25 | 122 |
| K162797 | Eneura, Inc. | SpringTMS | 2017-06-26 | 265 |
| K161663 | Eneura, Inc. | sTMS mini | 2016-08-23 | 68 |
| K140094 | Eneura Therapeutics, LLC | SPRINGTMS TOTAL MIGRAINE SYSTEM | 2014-05-21 | 127 |
Recalls for OKP devices
openFDA lists no recalls for product code OKP.
Frequently asked questions
What is FDA product code OKP?
OKP is the FDA product code for transcranial magnetic stimulator for the treatment of migraine headache. It is a Class II device, regulated under 21 CFR 882.5808 and reviewed by the Neurology panel.
What device class is OKP?
Class II, regulation 21 CFR 882.5808. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKP?
Across 5 cleared submissions the average was 135 days from receipt to decision (median 122).
Which companies have the most OKP clearances?
Eneura, Inc. (3); Eneura®, Inc. (1); Eneura Therapeutics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OKP
- Run a recall and safety report across every OKP manufacturer
- Watch product code OKP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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