21 CFR 882.5888 — Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5888

Identification

The Quell-FM is a wearable, transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The device stimulates sensory nerves in the upper-calf region through electrodes placed on the skin. It utilizes a microprocessor, embedded software, and a custom high-voltage Application Specific Integrated Circuit (ASIC) to generate current-regulated stimulating pulses. The device communicates via Bluetooth with a mobile app for therapy control and is powered by an embedded rechargeable lithium-ion battery.

Classification Rationale

Class II (special controls). The device is a prescription device that requires special controls to mitigate risks such as adverse tissue reactions, skin discomfort, burns, electrical shock, pain at the stimulation site, device failure due to interference, and delayed or ineffective treatment.

Product Codes