Data / Medical devices / United States / Neurometrix, Inc.
Neurometrix, Inc.: FDA-registered device maker in Rockaway, NJ, United States, 3 510(k) clearances
Neurometrix, Inc. is registered with the FDA (registration 3011412151) in Rockaway, NJ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011412151
- Address
- 200 Forge Way Ste 205, Rockaway, NJ, United States, 07866
- Owner or operator
- NEUROMETRIX, INC. (9034369)
- Roles
- Manufacturer
- First device listed
- April 27, 2015
- Registered through
- 2026
- Brand names listed
- Quell 2, Quell Electrode, Quell-FM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
| Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | QSQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2022 | DEN210046 | Quell-FM | QSQ | Unknown | Neurometrix, Inc. | accessdata.fda.gov |
| January 5, 2016 | K152954 | Quell | NUH | Substantially Equivalent | Neurometrix, Inc. | accessdata.fda.gov |
| November 17, 2014 | K140586 | ASCEND ELECTRODE | GXY | Substantially Equivalent | Neurometrix, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.