Quell
510(k) K152954
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152954 | Date5 Jan 2016 | StatusActive |
Official records
- FDA 510(k) database K152954
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NUH
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
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.
Similar devices
Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).
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- HI-DOW-XP by HI-DOW INTERNATIONAL INC.
- Neck Care Therapy, Model: SYK 509B by Shenzhen Osto Technology Co., Ltd.
- TENS7000 Rechargeable (Model:TENS7000 Rechargeable) by Chongqing Rob Linka Science and Technology Co., Ltd.
- Focus TENS Therapy, Model PM710-M/-L by Omron Healthcare, Inc.