FDA.reportPublic FDA data

E-LINK X4 Interface Unit

Primary DI
05060481690003
Brand
E-LINK X4 Interface Unit
Company
BIOMETRICS LIMITED
Model
X4
Catalog number
X4 MkIV plastic connectors
Device description
The X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session.Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.
Published
2018-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered
HCCDevice, Biofeedback
IONExerciser, Non-Measuring
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1
HCCDevice, BiofeedbackNeurology2
IONExerciser, Non-MeasuringPhysical Medicine1
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060481690003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060481690003050604816900035060481690003

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
519969810
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060481690454E-LINK Software (Version 16)16xx-xxx-xxxx2018-08-09
05060481691420SX230-1000 EMG SensorSX230-1000bandwidth 20-460 plastic connector2018-08-09
05060481691437SX230-1000 EMG SensorSX230-1000bandwidth 5-480 plastic connector2018-08-09
05060481691444SX230-1000 EMG SensorSX230-1000bandwidth 5-1000 plastic connector2018-08-09
05060481691451SX230-100 EMG SensorSX230-100Gain 100, bandwidth 20-460 plastic connector2018-08-09
05060481691468SX230FW EMG SensorSX230FWbandwidth 20-460 plastic connector2018-08-09
05060481691475SX230-1000 EMG SensorSX230-1000bandwidth 20-460 metal connector2018-08-10
05060481691482SX230-1000 EMG SensorSX230-1000bandwidth 5-480 metal connector2018-08-10
05060481691499SX230-1000 EMG SensorSX230-1000bandwidth 5-1000 metalconnector2018-08-10
05060481691505SX230-100 EMG SensorSX230-100Gain 100, bandwidth 20-460 metal connector2018-08-10
05060481691512SX230FW EMG SensorSX230FWbandwidth 20-460 metal connector2018-08-10
05060481690195E-LINK DG1 Wireless DongleDG12018-08-09
05060481690201E-LINK CA1 Battery ChargerCA12018-08-09
05060481690218E-LINK AD1 Wireless AdaptorAD12018-08-09
05060481690492E-LINK X4 Interface UnitX4X4 MkII metal connectors2018-08-09
05060481690607DataLITE DG2 Wireless DongleDG22018-08-09
05060481690614DataLITE CA2 Battery ChargerCA22018-08-09
05060481690621DataLITE AD2 Wireless AdaptorAD22018-08-09
05060481692465E-LINK EX2 Interface Unit for M400EX22018-08-10
05060481691666DataLOG MWX8MWX8MWX8 DataLOG - plastic connectors2018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08717524641085Lode B.V.Lode B.V.ISD2026-06-01
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07649998859059NUSHUMagnes AGISD2026-05-31
00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020919UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020926UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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