Data / Medical devices / United States / Neurosync, Inc.
Neurosync, Inc.: FDA-registered device maker in Holliston, MA, United States, 2 510(k) clearances
Neurosync, Inc. is registered with the FDA (registration 3014133165) in Holliston, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 2, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014133165
- Address
- 118 Washington Street Suite 14, Holliston, MA, United States, 01746
- Owner or operator
- NeuroSync, Inc. (10051621)
- Roles
- Manufacturer
- First device listed
- April 12, 2016
- Registered through
- 2026
- Brand names listed
- EYE-SYNC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | QEA | 2 | Manufacturer | accessdata.fda.gov |
| Nystagmograph | GWN | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 2, 2021 | K202927 | EYE-SYNC | QEA | Substantially Equivalent | Syncthink, Inc. | accessdata.fda.gov |
| January 29, 2016 | K152915 | EYE-SYNC | GWN | Substantially Equivalent | Syncthink, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 19, 2023 | 97014 | Class II | Ongoing | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking head | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- All makers of Nystagmograph
Updated July 11, 2025. 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.