OKP — Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache Class II
FDA product code OKP covers "Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache", a Class II medical device regulated under 21 CFR 882.5808. Submissions are reviewed by the Neurology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OKP
- Device Class
- Class II
- Regulation Number
- 882.5808
- Submission Type
- 510(k)
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230358 | Eneura | SAVI Dual (TM) Migraine Therapy | May 16, 2023 |
| K182976 | Eneura® | SpringTMS | Feb 25, 2019 |
| K162797 | Eneura | SpringTMS | Jun 26, 2017 |
| K161663 | Eneura | sTMS mini | Aug 23, 2016 |
| K140094 | Eneura Therapeutics | SPRINGTMS TOTAL MIGRAINE SYSTEM | May 21, 2014 |
| DEN130022 | Eneura Therapeutics | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | Dec 13, 2013 |