K221129 is an FDA 510(k) clearance for the CloudTMS for OCD. This device is classified as a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II - Special Controls, product code QCI).
Submitted by Teleemg, LLC (Los Angeles, US). The FDA issued a Cleared decision on March 10, 2023, 326 days after receiving the submission on April 18, 2022.
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 | K221129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2022 |
| Decision Date | March 10, 2023 |
| Days to Decision | 326 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). |