Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033273494

FEI Number

3033273494

Entity Name

NEUROTONE AI, INC

City/State/Country

Gainesville, FL, US

Establishment Address

6625 Nw 79th Ter, Gainesville, FL 32653, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Neurotone AI, Inc (Owner Number: 10091773)

Owner / Operator Contact Address

9200 NW 39th Avenue, Ste 130 #3237, Gainesville, FL 32606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lace Auditory Training Lace AI Pro Lace AI Lace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	Class 2	882.1470	2024-11-05

Official Correspondent

Richard Carlson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neurotone AI, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3043617526	AD SCIENTIAM	Paris Ile-de-France, FR
3032027298	Kneu Health Limited	London London, City of, GB
3026751369	NEUROWYZR PTE LTD.	Singapore Central Singapore, SG
3035679498	NEOTIV GMBH	Magdeburg Saxony-Anhalt, DE
3014129043	BRAINCHECK, INC.	Austin, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033273494. Last updated year: 2026. Please use registration number 3033273494 when referencing this establishment in official correspondence.