FDA.reportPublic FDA data

Lifelines iEEG Portable Yoga Tablet Wireless

Primary DI
05694110063014
Brand
Lifelines iEEG Portable Yoga Tablet Wireless
Company
Kvikna Medical ehf.
Model
KHW1022
Device description
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Published
2016-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143487000Lifelines iEEGKvikna Ehf2015-08-21OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694110063014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694110063014056941100630145694110063014

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, portableA mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500793540
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694110063007Lifelines iEEG Portable Yoga Tablet WiredKHW10202016-08-18
05694110063021Lifelines iEEG Portable Laptop System WiredKHW10102016-08-18
05694110063038Lifelines iEEG Portable Laptop System WirelessKHW10302016-08-18
05694110063045Lifelines iEEG Portable Laptop System No VideoKHW10402016-08-18
05694110063076Lifelines iEEG Portable Yoga Tablet No VideoKHW10502016-10-03
05694110063083Lifelines iEEG Clinical Desktop SystemKHW2050 2017-05-04
05694110063090Lifelines iEEGAcquisition 2017-11-09
05694110068057Stratus EEGServer Software2021-01-28
05694110068064Stratus EEGClient Software2021-01-28
05694110068071Stratus EEGAcquisition 2021-01-28
05694110063052Lifelines iEEG Client SoftwareKSW20502016-10-03
05694110063069Lifelines iEEG Server SoftwareKSW20602016-10-03
05694110068040Stratus EEGWeb2020-09-01

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