Qualisys Clinical System

GUDID 07300009074518

The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

Qualisys AB

Gait analysis system

• Primary Device ID: 07300009074518
• NIH Device Record Key: bacb1fb7-9f07-46ae-aa1f-d882e9b3ce0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qualisys Clinical System
• Version Model Number: 1.5.0.408
• Company DUNS: 632151952
• Company Name: Qualisys AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com
• Phone: 2246369833
• Email: support@qualisys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07300009074518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171547

FDA Product Code

• LXJ: Interactive Rehabilitation Exercise Devices

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: 2020-09-10
• Device Publish Date: 2020-09-02