OKP
6 FDA 510(k) clearances · Product code
127 daysmedian time to decision
283 days90th percentile
6clearances measured
FDA profile
- Official device name
- Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5808
- Medical specialty
- Neurology
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SAVI Dual (TM) Migraine Therapy (K230358) | Eneura, Inc. | 2023-05-16 | + Add |
| SpringTMS (K182976) | Eneura®, Inc. | 2019-02-25 | + Add |
| SpringTMS (K162797) | Eneura, Inc. | 2017-06-26 | + Add |
| sTMS mini (K161663) | Eneura, Inc. | 2016-08-23 | + Add |
| SPRINGTMS TOTAL MIGRAINE SYSTEM (K140094) | Eneura Therapeutics, LLC | 2014-05-21 | + Add |
| NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR (DEN130022) | Eneura Therapeutics | 2013-12-13 |
Track OKP automatically
Every clearance here is in the API, with alerts when new ones post.