# K981730: Digit-Grip with LCD, Model Number DGR 002

- Pathway: 510(k) (Traditional)
- Applicant: Nk Biotechnical Corp.
- Decided: Jul 17, 1998 after 63 days
- Product code: LBB (Dynamometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 888.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012492: Kadance 2000 (2001), 0 descendants of its own

## Indications for use
INDICATIONS FOR 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 strehglh 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.

Source page: https://510kreport.com/device/K981730
Methodology: https://510kreport.com/methodology