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510(k) Data Aggregation

    K Number
    K981730
    Device Name
    DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
    Manufacturer
    NK BIOTECHNICAL CORP.
    Date Cleared
    1998-07-17

    (63 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    NK BIOTECHNICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTIMATE System is indicated for use as follows: 1. to measure grip or pinch strength in an injured and uninjured hand. 2. to follow an injury through the rehabilitation process and measure progress or lack of progress, in terms of grip or pinch strength, of the therapy regimen or medical treatment. 3. to document baseline grip or pinch strength of the hands and lifting, pulling and pushing strength capabilities of employees and to monitor the strength of employees in the workplace over time. 4. generally, in 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 to his/her hand(s). 5. 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 (lifting, pulling and pushing protocols) in a simulated test. 6. to conduct pre-employment screening for physically demanding job activities.
    Device Description
    Not Found
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    K Number
    K970870
    Device Name
    DIGIT-GRIP WITH LCD (DGR002)
    Manufacturer
    NK BIOTECHNICAL CORP.
    Date Cleared
    1997-05-02

    (53 days)

    Product Code
    HRW
    Regulation Number
    888.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NK BIOTECHNICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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