510(k) K233742
K233742 is an FDA 510(k) premarket notification submitted by Teleemg, LLC for the device "CloudTMS Edge for OCD". The FDA issued a decision of Substantially Equivalent on December 22, 2023. The device falls under product code QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder), a Class II device regulated under 21 CFR 882.5802. Teleemg, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2023
- Date Received
- November 22, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device Class
- Class II
- Regulation Number
- 882.5802
- Review Panel
- NE
- Submission Type
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).