Final rule · 2026-12904

Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome

The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external lower extremity nerve stimulator for Restless Legs Syndrome. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.