Facility

NEUROSYNC, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

2warning letters

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

FDA Establishment Identifier (FEI)	3014133165
Establishment type	Manufacture Medical Device
Location	118 Washington Street Holliston, MA, US 01746
Registration status	Active · expires 2026
Parent company	NeuroSync, Inc. (owner-operator 10051621)
Brand names	EYE-SYNC

Activity by year

Recalls (1)
Inspections (2)
Warning letters (2)

Devices registered here (1)

Nystagmograph
Product code GWN (opens in a new tab) · Class II · Neurology · 21 CFR 882.1460

Recalls & enforcement

Class IIOngoing2023-09-19
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.

FDA inspections (2)

OAI2025-02-05
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-06-20
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

FDA warning letters (2)

Warning Letter2025-05-09
Warning Letter (opens in a new tab) · Holliston Massachusetts
Warning Letter2017-07-31
Warning Letter (opens in a new tab) · Holliston Massachusetts

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by NeuroSync, 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. “NEUROSYNC, INC. (FEI 3014133165) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014133165-neurosync-inc/

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