KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

FDA cleared the KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) from Fidelity BioPharma Co. on Sep 6, 2026 under K260396, a traditional 510(k). The device falls under product code OBP, Transcranial Magnetic Stimulator, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 6, 2026. The decision came 212 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Fidelity BioPharma Co. in the last 12 months of the tracker.