Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015491430

FEI Number

3015491430

Entity Name

Lifelines Neuro Company

City/State/Country

Louisville, KY, US

Establishment Address

900 East Main Street, STE 300, Louisville, KY 40206, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

LIFELINES LTD. (Owner Number: 9044781)

Owner / Operator Contact Address

1 TANNERY HOUSE, TANNERY LANE, WOKING, GB-SRY GU23 7EF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151600

PMA Number

N/A

All Registered Proprietary Names

Trackit MK3 TRACK IT Trackit T4 EEG Amplifier Trackit T4A EEG Amplifier Lifelines Photic Stimulator Photic R-40 EEG Amplifier

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2001-08-21
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2001-08-21
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2018-05-10
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-05-10
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2011-05-24
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2016-09-08
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2016-09-08

Official Correspondent

Chloe Mayo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LIFELINES LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710486	LIFELINES LTD.	WOKING Surrey, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015491430. Last updated year: 2026. Please use registration number 3015491430 when referencing this establishment in official correspondence.