Home GUDID 08809209590938 InBody
Primary DI 08809209590938
Brand InBody
Company InBody Co., Ltd.
Model FRA510(s)
Device description Ataxiagraph
Published 2023-06-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name GWW Ataxiagraph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWW Ataxiagraph Neurology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809209590938 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809209590938 08809209590938 8809209590938
GMDN Terms# Term, Definition table Term Definition Biomechanical function analysis system, motion-tracking A mains electricity (AC-powered) device assembly designed to track and evaluate the movement of the human body or body segments for the purpose of obtaining graphical visualization and biomechanical analysis of the body (e.g., spinal or joint movements). The device can also be used to determine the extent of ataxia (failure of muscular coordination) and will typically be used in the study of sports/work/rehabilitation related mechanisms/tasks; it is not dedicated to gait analysis alone. It may include various components to achieve its purpose [e.g., markers, sensors, video cameras, image processors, and computers].
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 688003404 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613336193242 Floodlight MS Pinching Test Roche Molecular Systems, Inc. GWW 2021-01-15 07613336193259 Floodlight MS Pinching Test Roche Molecular Systems, Inc. GWW 2021-01-15 07613336193280 Floodlight MS Draw Shape Test Roche Molecular Systems, Inc. GWW 2021-01-15 07613336193297 Floodlight MS Draw Shape Test Roche Molecular Systems, Inc. GWW 2021-01-15 07613336193334 Floodlight MS U-Turn Test Roche Molecular Systems, Inc. GWW 2021-01-15 07613336193341 Floodlight MS U-Turn Test Roche Molecular Systems, Inc. GWW 2021-01-15
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