ClearanceBrief
510(k) K260396 ยท OBP Transcranial Magnetic Stimulator

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

ApplicantFidelity BioPharma Co., New Haven CT, US
DecisionSubstantially Equivalent, Sep 6, 2026
ReceivedFeb 6, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260396

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.