Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011412151

FEI Number

3011412151

Entity Name

NEUROMETRIX, INC.

City/State/Country

Rockaway, NJ, US

Establishment Address

200 Forge Way Ste 205, Rockaway, NJ 07866, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEUROMETRIX, INC. (Owner Number: 9034369)

Owner / Operator Contact Address

200 Forge Way, Suite 205, Rockaway, NJ 07866, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140586

PMA Number

N/A

All Registered Proprietary Names

Quell-FM Quell 2 Quell Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSQ	Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms	Neurology	Class 2	882.5888	2023-10-06
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2016-10-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEUROMETRIX, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
3029924973	SHENZHEN SINREL TECH LTD	Shenzhen Guangdong, CN
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3011562129	MIRAE MEDI&TECH CO., LTD.	Cheonan-si Chungnam, KR
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011412151. Last updated year: 2026. Please use registration number 3011412151 when referencing this establishment in official correspondence.