AccessGUDID - DEVICE: KForce Muscle Controller (03770011995370)

GUDID

Device Identifier (DI) Information

Brand Name: KForce Muscle Controller
Version or Model: K Push V3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KINVENT BIOMECANIQUE

Primary DI Number: 03770011995370
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 269560516 *Terms of Use

Device Description: K Push is a hand held dynamometer used for the evaluation of muscles strength. You can assess isometric strength by the way of the peak force as well as of the average force for a specific muscle or muscle groups. The K Push allows to quantitatively measure the muscle strength and the deficit percentage caused by injury compared to the strength of the healthy side.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61672	Back/leg/chest dynamometer, electronic	A portable, hand-held, electrically-powered, digital instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess force generated during a variety of movements (e.g., leg abduction, lifting) and/or force required to be exerted by a clinician to overcome a patient’s resistance (break test techniques). Is typically used to test or control a patient's muscle strength as part of a rehabilitation program.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBB	Dynamometer, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e8517e1-bff0-4a18-882c-5af78e348994
Public Version Date: January 11, 2024
Public Version Number: 1
DI Record Publish Date: January 03, 2024