510(k) K243319
K243319 is an FDA 510(k) premarket notification submitted by Neuromodulatory Devices & Applications for the device "Ampa One System (AMPA-001)". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code OBP (Transcranial Magnetic Stimulator), a Class II device regulated under 21 CFR 882.5805. Neuromodulatory Devices & Applications has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2025
- Date Received
- October 23, 2024
- 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.