K230358 is an FDA 510(k) clearance for the SAVI Dual (TM) Migraine Therapy. This device is classified as a Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache (Class II - Special Controls, product code OKP).
Submitted by Eneura, Inc. (Baltimore, US). The FDA issued a Cleared decision on May 16, 2023, 95 days after receiving the submission on February 10, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5808. 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) Number | K230358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2023 |
| Decision Date | May 16, 2023 |
| Days to Decision | 95 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OKP - Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5808 |
| 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. |