K193006 is an FDA 510(k) clearance for the MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system. This device is classified as a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II - Special Controls, product code QCI).
Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on August 9, 2020, 286 days after receiving the submission on October 28, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5802. External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum)..
| 510(k) Number | K193006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2019 |
| Decision Date | August 09, 2020 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QCI - Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5802 |
| Definition | External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum). |