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510(k) Data Aggregation
K Number
K012492Device Name
KADANCE 2000
Manufacturer
KADA RESEARCH, INC.
Date Cleared
2001-11-02
(91 days)
Product Code
LBB
Regulation Number
888.1240Why did this record match?
Applicant Name (Manufacturer) :
KADA RESEARCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
To measure grip or pinch strength in an injured and uninjured hand.
To conduct pre-employment screening for physically demanding job activities.
To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.
Device Description
The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. The applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits simultaneously. The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.
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