Alert detail

Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

Policy ID: 2026-10675Specialty: Multi-specialtyAdded: 6/2/2026Effective: May 29, 2026federal rule

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What changed

Final Rule published 2026-05-29. The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms 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 transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms. We are taki

Who’s affected: Multi-specialty billing teams · Effective: May 29, 2026

Primary source: View the official CMS/MAC document ↗

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