Facility

Neuralynx, Inc.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3009391672
Establishment type	Manufacture Medical Device
Location	105 Commercial Dr Bozeman, MT, US 59715
Registration status	Active · expires 2026
Parent company	Neuralynx, Inc. (owner-operator 10038712)
Brand names	ATLAS Neurophysiology System

Activity by year

Recalls (1)

Devices registered here (1)

Reduced- Montage Standard Electroencephalograph
Product code OMC (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400

Recalls & enforcement

Class IIOngoing2022-03-14
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety te…

All facilities operated by Neuralynx, Inc.

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. “Neuralynx, Inc. (FEI 3009391672) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009391672-neuralynx-inc/

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