VICON

GUDID B548BONITASYSTEM0

VICON BONITA is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, spor

VICON MOTION SYSTEMS LIMITED

Gait analysis system

• Primary Device ID: B548BONITASYSTEM0
• NIH Device Record Key: 359b52b9-a438-4214-9f19-74838b27ac23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VICON
• Version Model Number: BONITA SYSTEM
• Company DUNS: 291642445
• Company Name: VICON MOTION SYSTEMS LIMITED
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3037998686
• Email: support@vicon.com
• Phone: 3037998686
• Email: support@vicon.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B548BONITASYSTEM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811172

FDA Product Code

• LXJ: System, Optical Position/Movement Recording

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-18

On-Brand Devices [VICON]

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• B548VICONVANTAGESYSTEM0: VICON Vantage is a system for motion analysis, intended for the recording and analysis of human
• B548VICONTSERIESSYSTEM0: VICON T Series is a system for motion analysis, intended for the recording and analysis of human
• B548BONITASYSTEM0: VICON BONITA is a system for motion analysis, intended for the recording and analysis of human m