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Lifelines Neuro Company: FDA-registered device maker in Louisville, KY, United States, 4 510(k) clearances

Name: Lifelines Neuro Company FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lifelines Neuro Company is registered with the FDA (registration 3015491430) in Louisville, KY, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 4, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015491430
Address: 900 East Main Street STE 300, Louisville, KY, United States, 40206
Owner or operator: LIFELINES LTD. (9044781)
Roles: Complaint file establishment
First device listed: August 21, 2001
Registered through: 2026
Brand names listed: Lifelines Photic Stimulator, Photic, R-40 EEG Amplifier, TRACK IT, Trackit MK3, Trackit T4 EEG Amplifier, Trackit T4A EEG Amplifier

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Complaint file establishment	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Complaint file establishment	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Complaint file establishment	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
May 4, 2018	K172271	Trackit T4 EEG Amplifier	GWQ	Substantially Equivalent	Lifelines , Ltd.	accessdata.fda.gov
October 23, 2015	K151600	R-40 EEG Amplifier	GWL	Substantially Equivalent	Lifelines , Ltd.	accessdata.fda.gov
August 10, 2010	K101691	LIFELINES PHOTIC STIMULATOR	GWE	Substantially Equivalent	Lifelines , Ltd.	accessdata.fda.gov
May 14, 2001	K010460	LIFELINES TRACKIT	OLV	Substantially Equivalent	Lifelines , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 11, 2019	84270	Class II	Terminated	ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtain	Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.	accessdata.fda.gov

Compare with other makers

Updated May 4, 2018. 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.