Facility

NEURONETRIX SOLUTIONS, LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011184129
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	1044 E Chestnut St Ste 8 Louisville, KY, US 40204
Registration status	Active · expires 2026
Parent company	Neuronetrix Solutions, LLC (owner-operator 10048856)
Brand names	GWJ / STIMULATOR, AUDITORY, EVOKED RESPONSE

Activity by year

Recalls (1)
Inspections (4)

Devices registered here (3)

Stimulator, Auditory, Evoked Response
Product code GWJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1900
Non-Normalizing Quantitative Electroencephalograph Software
Product code OLT (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
Reduced- Montage Standard Electroencephalograph
Product code OMC (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400

Recalls & enforcement

Class IITerminated2019-11-07
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia

FDA inspections (4)

VAI2024-11-07
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-11-07
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-07-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-07-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Neuronetrix Solutions, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NEURONETRIX SOLUTIONS, LLC (FEI 3011184129) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011184129-neuronetrix-solutions-llc/

Not open yet

Alerts for NEURONETRIX SOLUTIONS, LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.