OKP — Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache Class II
Classification Details
- Product Code
- OKP
- Device Class
- Class II
- Regulation Number
- 882.5808
- Submission Type
- 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 | February 25, 2019 |
| K162797 | eneura | SpringTMS | June 26, 2017 |
| K161663 | eneura | sTMS mini | August 23, 2016 |
| K140094 | eneura therapeutics | SPRINGTMS TOTAL MIGRAINE SYSTEM | May 21, 2014 |
| DEN130022 | eneura therapeutics | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | December 13, 2013 |