DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002

K981730 · Nk Biotechnical Corp. · LBB · Jul 17, 1998 · Orthopedic

Device Facts

• Record ID: K981730
• Device Name: DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
• Applicant: Nk Biotechnical Corp.
• Product Code: LBB · Orthopedic
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1240
• Device Class: Class 2

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 Story

Digit-Grip with LCD (Model DGR 002) is a hand-held dynamometer designed to measure grip and pinch strength. Device captures mechanical force applied by user's hand; transforms input into digital readout via integrated LCD screen. Used in clinical rehabilitation settings by therapists/physicians to track recovery progress, and in industrial/occupational settings for pre-employment screening or job-duty matching. Provides objective strength data to assist clinicians in evaluating hand function or employers in assessing physical capability for specific tasks. Benefits include standardized documentation of strength metrics and monitoring of therapeutic efficacy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hand-held dynamometer with integrated LCD display for force measurement. Device operates as a mechanical force transducer. Form factor is a portable, hand-held unit. No specific materials, connectivity, or software algorithm details provided.

Indications for Use

Indicated for individuals requiring assessment of hand grip or pinch strength, including those with hand injuries or diseases, and for employees undergoing workplace strength testing, pre-employment screening, or monitoring of lifting/pulling/pushing capabilities.

Regulatory Classification

Identification

An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 17 1998

Ms. Karen Gotfredson · President NK Biotechnical Corporation 10850 Old County Road 15 Minneapolis, Minnesota 55441

Re: K981730 Digit-Grip with LCD, Model DGR 002 Trade Name: Regulatory Class: II Product Code: LBB Dated: May 12, 1998 Received: May 15, 1998

## Dear Ms. Gotfredson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Karen Gotfredson

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Accessories for Dicit - grip with Device Name: /

Model # Ibrooz

Indications For Use:

Karen Gayfriedson
President

## 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 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).
- న. 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(DIVISION Sign-Off)
DX of General Restorative Devdass 1981730
510(k) Number

Prescription الاقت (Per 21 CFR 801.109)

OR .

Over-The-Counter Use X

(Optional Format 1-2-96)

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