Data / Medical devices / United States / Neuronetrix Solutions, LLC

Neuronetrix Solutions, LLC: FDA-registered device maker in Louisville, KY, United States, 1 510(k) clearance

Name: Neuronetrix Solutions, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neuronetrix Solutions, LLC is registered with the FDA (registration 3011184129) in Louisville, KY, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011184129
Address: 1044 E Chestnut St Ste 8, Louisville, KY, United States, 40204
Owner or operator: Neuronetrix Solutions, LLC (10048856)
Roles: Specification developer
First device listed: March 11, 2015
Registered through: 2026
Brand names listed: GWJ / STIMULATOR, AUDITORY, EVOKED RESPONSE

Devices it lists

Device	Product code	Class	Role	Source
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Specification developer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Specification developer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Specification developer	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
February 13, 2015	K141316	COGNISION EEG/EP SYSTEM	OLT	Substantially Equivalent	Neuronetrix Solutions	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 7, 2019	84324	Class II	Terminated	Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconduc	Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia	accessdata.fda.gov

Compare with other makers

Updated February 13, 2015. 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.