K182976 is an FDA 510(k) clearance for the SpringTMS. 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. (Sunnyvale, US). The FDA issued a Cleared decision on February 25, 2019, 122 days after receiving the submission on October 26, 2018.
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 | K182976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2018 |
| Decision Date | February 25, 2019 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| 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. |