QSQ · Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
Neurology · 21 CFR 882.5888 · Class 2
Overview
| Product Code | QSQ |
|---|---|
| Device Name | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms |
| Regulation | 21 CFR 882.5888 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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.
Special Controls
In combination with the general controls of the FD&C Act. the transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN210046 | Quell-FM | Neurometrix, Inc. | May 18, 2022 | DENG |
Top Applicants
- Neurometrix, Inc. — 1 clearance
