AccessGUDID - DEVICE: VICON (B548VICONVANTAGESYSTEM0)

GUDID

Device Identifier (DI) Information

Brand Name: VICON
Version or Model: VANTAGE SYSTEM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VICON VANTAGE SYSTEM
Company Name: VICON MOTION SYSTEMS LIMITED

Primary DI Number: B548VICONVANTAGESYSTEM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 291642445 *Terms of Use

Device Description: VICON Vantage is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine,ergonomics, clinical research and gait analysis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35757	Gait analysis system	An assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXJ	System, Optical Position/Movement Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K811172	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e295f75-fd6e-4cb0-9d86-53966efdd8d6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 18, 2017