510(k) K233631
K233631 is an FDA 510(k) premarket notification submitted by Revital Lab, Inc. for the device "ZapStim Controller Application (Z1023)". The FDA issued a decision of Substantially Equivalent on February 9, 2024. The device falls under product code OBP (Transcranial Magnetic Stimulator), a Class II device regulated under 21 CFR 882.5805.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2024
- Date Received
- November 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulator
- Device Class
- Class II
- Regulation Number
- 882.5805
- Review Panel
- NE
- Submission Type
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.