E-LINK X4 Interface Unit

Basic Information

• Brand Name: E-LINK X4 Interface Unit
• Primary DI: 05060481690003
• Version / Model: X4
• Catalog Number: X4 MkIV plastic connectors
• Company Name: BIOMETRICS LIMITED
• Labeler DUNS: 519969810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-14
• Public Version: 7
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 4405dfee-dd97-4afa-a35c-9ded1898e697

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCC	Device, Biofeedback	Neurology	882.5050	2
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2
BXB	Exerciser, Powered	Physical Medicine	890.5380	1
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060481690003	GS1