Nalu Neurostimulation SCS system

Nalu Neurostimulation SCS system is an FDA 510(k)-cleared medical device (K201618) manufactured by Boston Scientific Neuromodulation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2020. Regulation: 8.