
Neuraxis
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NeurAxis IB-Stim (01-1020) is an FDA 510(k)-cleared medical device (K250451) manufactured by Neuraxis. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2025. Regulation: 8.