Hand Evaluation Kit - The Lafayette Grip or Pinch Dynamometers are - LAFAYETTE INSTRUMENT COMPANY, INC.

Duns Number:005080650

Device Description: The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. Th The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. They are designed for routine assessment of the grip and/or pinch strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient either grips or pinches the device, a column of hydraulic fluid activates a pressure gauge mounted on the top of the device. The gauge indicates the pinch or grip force in pounds (lbs) or kilogram force (kgf). A peak needle shows the maximum force applied during a single test. The peak needle is manually reset at the end of the test and peak values are recorded manually. The grip dynamometers also feature an adjustable handle that can accommodate five different grip positions. The Stainless Steel Short Finger Goniometer is used for easy range-of-motion measurements of metacarpal, phalangeal, and interphalangeal joints. There are linear inch and centimeter markings on both sides of the protractors, in opposite directions. The protractors measure 0-150° in 5° increments. Stainless steel. Latex free. Clearly marked numbers make measuring easy. Measures 5.75 inches long.

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More Product Details

Catalog Number

J00109

Brand Name

Hand Evaluation Kit

Version/Model Number

J00109

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HRW

Product Code Name

Dynamometer, Nonpowered

Device Record Status

Public Device Record Key

7ae8d90d-209f-4363-8737-70894720f82a

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LAFAYETTE INSTRUMENT COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21