FDA.reportPublic FDA data

Trackit Sleepwalker

Primary DI
05060275450127
Brand
Trackit Sleepwalker
Company
LIFELINES LIMITED
Model
MK3 Standard
Catalog number
1301
Published
2019-01-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010460000LIFELINES TRACKITLifelines , Ltd.2001-05-14OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060275450127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060275450127050602754501275060275450127

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

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
05060275450134Trackit SleepwalkerMK3 + SaO213022019-01-18
05060275450141Trackit SleepwalkerMK3 + BT13032019-01-18
05060275450158Trackit SleepwalkerMK3 + SaO2 + BT13042019-01-18
05060275450172TrackitTrackit 3 BT 24/811882016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
00850049266055WavebandBeacon Biosignals, Inc.OLV2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLV2026-04-17
B566847020ZmachineGeneral SleepOLV2026-04-16
B566847001ZmachineGeneral SleepOLV2026-04-09
B566847002ZmachineGeneral SleepOLV2026-04-09
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
00840067104224CadwellCADWELL INDUSTRIES, INC.OLV2026-03-02
00840067104217CadwellCADWELL INDUSTRIES, INC.OLV2026-03-01
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2025-12-22
00817111021332PolysmithNeurotronics, LLCOLV2025-09-23
00850063034128Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2025-01-28
00850063034142Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2025-01-28
00850063034159Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2025-01-28