AccessGUDID - DEVICE: K Myo (03770011995707)

GUDID

Device Identifier (DI) Information

Brand Name: K Myo
Version or Model: K Myo V3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KINVENT BIOMECANIQUE

Primary DI Number: 03770011995707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 269560516 *Terms of Use

Device Description: K Myo is a biofeedback device for training muscle groups by means of electromyography

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?
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

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
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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: 5d9b7107-0556-4cc6-9801-a07f1c557181
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024