DEVICE: VICON (B548BONITASYSTEM0)

Device Identifier (DI) Information

VICON
BONITA SYSTEM
In Commercial Distribution

VICON MOTION SYSTEMS LIMITED
B548BONITASYSTEM0
HIBCC

1
291642445 *Terms of Use
VICON BONITA 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
LXJ System, Optical Position/Movement Recording
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FDA Premarket Submission

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

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

359b52b9-a438-4214-9f19-74838b27ac23
July 06, 2018
3
April 18, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Customer Contact

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3037998686
support@vicon.com
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