E-LINK Software (Version 16)

GUDID 05060481690454

E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical appli

BIOMETRICS LIMITED

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• Primary Device ID: 05060481690454
• NIH Device Record Key: e96f4693-f2bb-49a7-81e9-792b8fb02b5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-LINK Software (Version 16)
• Version Model Number: 16xx-xxx-xxxx
• Company DUNS: 519969810
• Company Name: BIOMETRICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060481690454 [Primary]

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-10
• Device Publish Date: 2018-08-09

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• 05060481690119 - E-LINK Myo-EX GX4 EMG Sensor: 2018-09-10 Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of volu
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• 05060481690195 - E-LINK DG1 Wireless Dongle: 2018-09-10 The wireless Dongle (DG1) enables E-LINK to be used as a complete stand-alone wireless evaluation and exercise system.This produ