FDA Product Code GWF: Stimulator, Electrical, Evoked Response

Under FDA product code GWF, evoked response electrical stimulators are cleared for intraoperative neurophysiological monitoring.

These devices deliver controlled electrical stimuli to sensory or motor pathways to evoke measurable neural responses that indicate the integrity of specific neural structures. They are used in spinal, cerebrovascular, and skull base surgery to detect neural compromise before permanent injury occurs.

GWF devices are Class II medical devices, regulated under 21 CFR 882.1870 and reviewed by the FDA Neurology panel.

Leading manufacturers include Cadwell Laboratories, Inc., Axon Systems, Inc. and Nihon Kohden America, Inc..