K231350 is an FDA 510(k) clearance for the OCD MT Cap (85-00397-000). This device is classified as a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II - Special Controls, product code QCI).
Submitted by Neuronetics (Malvern, US). The FDA issued a Cleared decision on June 8, 2023, 30 days after receiving the submission on May 9, 2023.
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 | K231350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2023 |
| Decision Date | June 08, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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). |