Lafayette Hydraulic Grip Dynamometer

Basic Information

• Brand Name: Lafayette Hydraulic Grip Dynamometer
• Primary DI: 00855170007218
• Version / Model: J00105
• Catalog Number: J00105
• Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.
• Labeler DUNS: 005080650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-31
• Public Version: 1
• Public Version Date: 2021-09-08
• Public Version Status: New
• Public Device Record Key: 7452a2a2-6462-43fb-8ed9-75e6c59ea843

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRW	Dynamometer, Nonpowered	Orthopedic	888.1250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35021	Hand dynamometer/pinchmeter, mechanical	A non-powered, mechanical instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip and/or pinch strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke. This device is commonly known as a Vigorimeter. It typically consists of various size squeeze bulbs and an analogue manometer to record the exerted effort. The patient will typically be asked to perform the test a few times so that the physician can obtain a mean value.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855170007218	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit