Neuronetrix Solutions, LLC

Louisville, KY, US

NEURONETRIX SOLUTIONS, LLC appears in FDA device records in Louisville, KY. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Neuronetrix Solutions, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Neuronetrix Solutions, LLC dba Cognisionenforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Neuronetrix Solutions, LLC in 2015.

Clearances by year, as a table

510(k) clearance decisions for Neuronetrix Solutions, LLC, by decision year
Year	Clearances
2015	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K141316	COGNISION EEG/EP SYSTEM	OLT	Substantially Equivalent	2015-02-13

Registered establishments

FDA registered establishments for Neuronetrix Solutions, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011184129	3011184129	NEURONETRIX SOLUTIONS, LLC	1044 E Chestnut St Ste 8, Louisville, KY 40204 US	2026	GWJ OLT OMC

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0675-2020	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 electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep cups are a component in the Subject Kit.	Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia	Class II	2019-11-07	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain