FDA.reportPublic FDA data

Trackit T4

Primary DI
05060275450554
Brand
Trackit T4
Company
LIFELINES LIMITED
Model
T4-68 + BT Kit
Published
2018-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151600000
K172271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151600000R-40 EEG AmplifierLifelines , Ltd.2015-10-23GWL
K172271000Trackit T4 EEG AmplifierLifelines , Ltd.2018-05-04GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060275450554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060275450554050602754505545060275450554

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic ambulatory recorderAn electrically-powered device designed for 24-hour recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders. It typically includes a small cassette tape recorder or a digital medium (no moving parts) with appropriate signal amplifiers worn by the patient, and a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) is typically analysed in an electroencephalographic analyser.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441483224245wayne.williams@llines.com

Regulatory Flags#

DUNS number
237089235
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060275450714R-40 (24)Amp14112020-01-27
05060275450721R-40 (24)Amp + BT14122020-01-27
05060275450738R-40 (24)Amp + WI-FI14132020-01-27
05060275450745R-40 (24)Amp + BT + WI-FI14142020-01-27
05060275450752R-40 (24)Amp Kit26042020-01-27
05060275450769R-40 (24)Amp + BT Kit26052020-01-27
05060275450776R-40 (24)Amp + WI-FI Kit26062020-01-27
05060275450783R-40 (24)Amp + BT + WI-FI Kit26072020-01-27
05060275450004TrackitTrackit 3 BT 24/011872016-09-09
05060275450011TrackitTrackit 3 BT 20/411842016-09-09
05060275450028TrackitTrackit 3 BT 18/811852016-09-09
05060275450035TrackitTrackit 3 BT 32/011862016-09-09
05060275450042TrackitTrackit 3 BT 24/0/B11722016-09-09
05060275450059TrackitTrackit 3 BT 20/4/B11692016-09-09
05060275450066TrackitTrackit 3 BT 18/8/B11702016-09-09
05060275450073TrackitTrackit 3 BT 32/0/B11712016-09-09
05060275450127Trackit SleepwalkerMK3 Standard13012019-01-18
05060275450134Trackit SleepwalkerMK3 + SaO213022019-01-18
05060275450141Trackit SleepwalkerMK3 + BT13032019-01-18
05060275450158Trackit SleepwalkerMK3 + SaO2 + BT13042019-01-18

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