ClearanceBrief
510(k) K250451 ยท QHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

NeurAxis IB-Stim (01-1020)

ApplicantNeuraxis, Carmel IN, US
DecisionSubstantially Equivalent, May 15, 2025
ReceivedFeb 18, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250451

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.