Device type
Transcranial Magnetic Stimulator
Product code OBP · Class II · 21 CFR 882.5805 · Neurology
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.
Recent 510(k)s
Sep 6, 2026
K260396
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Fidelity BioPharma Co.
- OBP
- Class II
Aug 23, 2026
K260691
BTL-699
BTL Industries, Inc.
- OBP
- Class II
Recent recalls
Oct 21, 2026
Z-0142-2027
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. N…
Neuronetics, Inc.
- OBP
- Class II
- Ongoing