Identifiers
- 510(k) Number
- K152954 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Quell is a wearable pain relief device that uses nerve stimulation technology to deliver relief from chronic pain. It is a FDA Class II medical device designed for day and night use, providing pain relief during activity or sleep.
The device is supplied as a wearable system and is authorized under FDA 510K clearance with product code NUH. It is manufactured by Neurometrix, Inc. and is available for use in treating chronic pain conditions.
Frequently asked questions
What is Quell used for?
Quell is a wearable pain relief device designed to provide relief from chronic pain through nerve stimulation technology. It can be used during both day and night activities to help manage chronic pain conditions.
How is Quell supplied?
Quell is supplied as a complete wearable system that includes the device, electrodes, and necessary accessories. It is designed for ease of use and comes ready to apply for immediate pain relief.
Is Quell a single-use or reusable device?
Quell is designed for repeated use rather than single-use. The device can be worn continuously and is intended to provide ongoing pain relief as needed by the user.
What regulatory approvals does Quell have?
Quell is authorized under FDA 510K clearance with product code NUH. It received FDA clearance in 2016 as a Class II medical device for the treatment of chronic pain conditions.
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: NeuroMetrix, electroCore Completes Acquisition of NeuroMetrix, Gaining Access to its ..., What is Quell? - NeuroMetrix
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152954 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurometrix, Inc.
Sources (1)
- FDA 510(k) K152954 24 fields · synced Sep 25, 2026