K243459 is an FDA 510(k) clearance for the Ultimate rTMS for OCD (M-series). This device is classified as a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II - Special Controls, product code QCI).
Submitted by Brain Ultimate, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 17, 2025, 160 days after receiving the submission on November 8, 2024.
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 | K243459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | April 17, 2025 |
| Days to Decision | 160 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). |