K160309 is an FDA 510(k) clearance for the Neurosoft TMS. This device is classified as a Transcranial Magnetic Stimulator (Class II - Special Controls, product code OBP).
Submitted by Teleemg, LLC (Woburn, US). The FDA issued a Cleared decision on December 22, 2016, 322 days after receiving the submission on February 4, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5805. A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder..
| 510(k) Number | K160309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OBP - Transcranial Magnetic Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5805 |
| Definition | A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder. |