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Business · 16/04/2026

FDA Classifies Transcutaneous Electrical Nerve Stimulator for Congestion Relief

The FDA is classifying the transcutaneous electrical nerve stimulator for the relief of congestion into Class II, citing a reasonable assurance of safety and effectiveness, and aims to reduce regulatory burdens, enhancing patients' access to innovative devices.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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