KINVENT

Basic Information

• Brand Name: KINVENT
• Primary DI: 03770011995332
• Version / Model: Grip V2R01
• Company Name: KINVENT HELLAS
• Labeler DUNS: 524664525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-01
• Public Version: 2
• Public Version Date: 2021-11-30
• Public Version Status: Update
• Public Device Record Key: 15093b4a-56d4-4321-bfc1-8956f4e39cbc

Device Description

Grip is used for the evaluation of hand grip strength. You can assess isometric strength by the way of the peak force as well as of the average force. The Grip dynamometer allows to quantitatively measure the grip weakness caused by injury compared to the strength of the healthy hand

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: Yes
• 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
LBB	Dynamometer, Ac-Powered	Orthopedic	888.1240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33785	Hand dynamometer/pinchmeter, electronic	An electrically-powered 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 strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke; it may in addition be designed to be used as part of an interactive rehabilitation system whereby forces applied by the patient translate to movements in a video-game. It includes a force transducer to translate force into electrical impulses for measurement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03770011995332	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius