FDA.reportPublic FDA data

Lifelines Photic Stimulator

Primary DI
05060275450707
Brand
Lifelines Photic Stimulator
Company
LIFELINES LIMITED
Model
Photic Stimulator Kit
Published
2019-07-04
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
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101691000LIFELINES PHOTIC STIMULATORLifelines , Ltd.2010-08-10GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060275450707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060275450707050602754507075060275450707

GMDN Terms#

Term, Definition table
TermDefinition
Visual stimulatorAn electronic device used to apply visual stimuli (e.g., shifting patterns of light) to a patient's eyes. This device typically presents light to the eye through an optical system (optical stimulator), or light is viewed directly from an illuminated screen (direct-view stimulator), or light-emitting diode (LED) stimulating goggles. It is typically used as a component of several other devices such as refractors, scanning ophthalmoscopes, visual evoked potential (VEP) recording systems, or an electroretinograph (ERG).

Contacts#

Phone, Email table
PhoneEmail
+441483224245wayne.williams@lifelinesneuro.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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857901006620RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWE2025-05-19
08056446900185USB FLASH ADAPTER CABLE L=3mEB NEURO SPAGWE2024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mEB NEURO SPAGWE2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04