510(k) K230358
K230358 is an FDA 510(k) premarket notification submitted by Eneura, Inc. for the device "SAVI Dual (TM) Migraine Therapy". The FDA issued a decision of Substantially Equivalent on May 16, 2023. The device falls under product code OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache), a Class II device regulated under 21 CFR 882.5808. Eneura, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2023
- Date Received
- February 10, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
- Device Class
- Class II
- Regulation Number
- 882.5808
- Review Panel
- NE
- Submission Type
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.