K222171 is an FDA 510(k) clearance for the Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+. This device is classified as a Transcranial Magnetic Stimulator (Class II - Special Controls, product code OBP).
Submitted by Magstim Company, Ltd. (Whitland, GB). The FDA issued a Cleared decision on January 13, 2023, 176 days after receiving the submission on July 21, 2022.
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 | K222171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2022 |
| Decision Date | January 13, 2023 |
| Days to Decision | 176 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. |