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510(k) Data Aggregation
K Number
K981730Device 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
888.1240Why 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
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K Number
K970870Device Name
DIGIT-GRIP WITH LCD (DGR002)
Manufacturer
NK BIOTECHNICAL CORP.
Date Cleared
1997-05-02
(53 days)
Product Code
HRW
Regulation Number
888.1250Why 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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