Federal Register #2026-12904

FDA Classifies External Nerve Stimulator for Restless Legs Syndrome as Class II Device

This notice announces the FDA's final order classifying the external lower extremity nerve stimulator for Restless Legs Syndrome as a Class II medical device with special controls. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Noctrix Health, Inc. (referenced as the requester for De Novo classification) - Products/Services: - External lower extremity nerve stimulator for Restless Legs Syndrome - Example: NTX100 Tonic Motor Activation (NTX100 ToMAc) System - Prescription device using external electrical stimulation and cutaneous electrodes to activate nerves in the lower extremity - Unique/Notable Requirements: - Device classified as Class II with special controls - Special controls include: - Non-clinical performance testing - Biocompatibility assessment - Electrical and mechanical safety testing - Software validation - Specific labeling for physicians and patients - Classification intended to ensure safety and effectiveness, reduce regulatory burden, and improve patient access - No procurement, purchase quantities, or part numbers are specified in this notice

Description

The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome into class II with special controls. This device is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity to reduce symptoms of Restless Legs Syndrome. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens to improve patient access to innovative devices. The order is effective June 26, 2026, with classification applicable from April 17, 2023.

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