K161663 is an FDA 510(k) clearance for the sTMS mini. 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 August 23, 2016, 68 days after receiving the submission on June 16, 2016.
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 | K161663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2016 |
| Decision Date | August 23, 2016 |
| Days to Decision | 68 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. |