Quell-FM Transcutaneous Electrical Nerve Stimulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN210046 FDA 510(k)
- FDA Product Code
- QSQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5888 FDA 510(k)
- Regulation Number
- 882.5888 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Quell-FM is a transcutaneous electrical nerve stimulation (TENS) device classified as a Class 2 Neurology device (product code QSQ). It is designed to provide electrical stimulation to help reduce fibromyalgia symptoms in adults with high pain sensitivity, leveraging transcutaneous nerve modulation to alleviate discomfort. The device operates on the principle of delivering low-level electrical impulses through the skin to modulate pain perception. Its regulatory designation aligns with the FDA’s classification for neuromodulation devices intended for chronic pain management.
The Quell-FM is intended for use during sleep and is supplied with compatible NeuroMetrix electrodes. It is cleared under FDA 510(k) (DEN210046) via the Direct pathway, adhering to regulatory standards for Class 2 devices. No explicit sterility or single-use/reusable designation is provided, though its intended use suggests a reusable design with proper electrode maintenance. The device is not labeled for MRI compatibility or other imaging environments. Storage and handling follow standard electrical medical device protocols as outlined in its user manual.
Frequently asked questions
What specific symptoms related to fibromyalgia does the Quell-FM aim to help manage, and how does it work to achieve this?
The Quell-FM is designed to help reduce fibromyalgia symptoms in adults with high pain sensitivity, particularly focusing on discomfort. It works by delivering low-level electrical impulses through the skin via transcutaneous nerve modulation, which helps modulate pain perception during sleep. This approach leverages neuromodulation principles to alleviate chronic pain associated with fibromyalgia.
Is the Quell-FM intended for use during sleep, and what does this imply about its design and operation?
Yes, the Quell-FM is explicitly intended for use during sleep. This design choice implies the device is likely low-profile, quiet, and optimized for continuous, uninterrupted operation without requiring active user engagement. Its compatibility with NeuroMetrix electrodes suggests electrodes are placed before sleep and remain in place throughout, delivering stimulation automatically while the user rests.
How is the Quell-FM supplied, and what considerations should be made regarding electrode maintenance?
The Quell-FM is supplied with compatible NeuroMetrix electrodes, which are intended for repeated use. Since the device is not explicitly labeled as single-use or sterile, proper electrode maintenance—such as cleaning and storage—is critical to ensure hygiene and functionality over multiple sessions. Users should follow the manufacturer’s guidelines for electrode care to avoid skin irritation or infection.
What regulatory pathway was used for FDA clearance of the Quell-FM, and what does this mean for its oversight?
The Quell-FM was cleared via the FDA’s Direct pathway under 510(k) (DEN210046), which is a streamlined process for Class 2 devices demonstrating substantial equivalence to a predicate device. This pathway ensures the device meets FDA standards for safety and effectiveness as a transcutaneous electrical nerve stimulator for fibromyalgia symptom management, with ongoing compliance monitored through standard regulatory channels.
Are there any special handling or storage requirements for the Quell-FM beyond typical electrical medical device protocols?
While the Quell-FM follows standard electrical medical device storage and handling protocols, users should adhere to the manufacturer’s user manual for specific instructions. Since it is intended for reusable electrode use, electrodes should be stored in a clean, dry environment when not in use to prevent contamination. The device itself should be kept away from extreme temperatures, moisture, or direct sunlight, as with any electronic medical equipment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF DEN210046-S001.Letter.DENG.pdf - Food and Drug Administration, DEN210046 - Quell-FM FDA 510 (k) APPLICATION FOR NeuroMetrix, Inc., DEN210046 - Quell-FM | FDA 510 (k) | Neurometrix, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN210046 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurometrix, Inc.
Sources (1)
- FDA 510(k) DEN210046 24 fields · synced Sep 20, 2026