DEVICE: DataLINK DLK900 (05060481691925)
Device Identifier (DI) Information
DataLINK DLK900
DLK900
In Commercial Distribution
DataLINK DLK900 - plastic connectors
BIOMETRICS LIMITED
DLK900
In Commercial Distribution
DataLINK DLK900 - plastic connectors
BIOMETRICS LIMITED
DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches.
This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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17929 | 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].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IKK | System, Isokinetic Testing And Evaluation |
KQX | Goniometer, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
e6ea5624-f09b-468a-9366-68c4847ab5a6
September 10, 2018
1
August 10, 2018
September 10, 2018
1
August 10, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined