Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
The Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache (product code OKP) is a Class 2 neurological device regulated under 21 CFR 882.5808 in the Neurology specialty (NE), cleared via 510(k). It delivers brief-duration, rapidly alternating or pulsed magnetic fields externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headaches. The device is not an implant and is not life-sustaining or life-supporting.
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Basic Information
- Product Code
- OKP
- Device Class
- FDA class 2
- Regulation Number
- 882.5808
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230358 | SAVI Dual (TM) Migraine Therapy | May 16, 2023 | Substantially Equivalent | Eneura, Inc. |
| K182976 | SpringTMS | Feb 25, 2019 | Substantially Equivalent | Eneura®, Inc. |
| K162797 | SpringTMS | Jun 26, 2017 | Substantially Equivalent | Eneura, Inc. |
| K161663 | sTMS mini | Aug 23, 2016 | Substantially Equivalent | Eneura, Inc. |
| K140094 | SPRINGTMS TOTAL MIGRAINE SYSTEM | May 21, 2014 | Substantially Equivalent | Eneura Therapeutics, LLC |
| DEN130022 | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | Dec 13, 2013 | Unknown | Eneura Therapeutics |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.