DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002

• 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

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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a device for measuring grip and pinch strength and does not mention any AI or ML capabilities.

Therapeutic

No
The device is indicated for measuring and monitoring strength, not for treating conditions or injuries. Its purpose is diagnostic and evaluative, not therapeutic.

Diagnostic

Yes
The device is used to measure strength and track progress following an injury or disease, which falls under the definition of a diagnostic device as it provides information for the identification, assessment, or monitoring of a medical condition.

SaMD (Software as a Medical Device)

Unknown

The provided text only describes the intended use of the device. Without a device description, it is impossible to determine if the device is software-only or includes hardware components. The intended use of measuring grip and pinch strength strongly suggests the need for a physical sensor or transducer, which would be a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, the ULTIMATE System is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• ULTIMATE System Function: The ULTIMATE System measures physical strength (grip, pinch, lifting, pulling, pushing). It interacts directly with the human body to assess a physical capability.
• Intended Use: The intended uses listed all relate to assessing physical strength for purposes like rehabilitation, workplace evaluation, and pre-employment screening. None of these involve analyzing biological samples.

Therefore, the ULTIMATE System falls under the category of a physical measurement or assessment device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended 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 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.

Product codes

LBB

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand(s)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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)