AccessGUDID - DEVICE: Korebalance Premiere (00858458007009)

GUDID

Device Identifier (DI) Information

Brand Name: Korebalance Premiere
Version or Model: KB01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diversified Healthcare Development, LLC

Primary DI Number: 00858458007009
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 048174391 *Terms of Use

Device Description: The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.

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?
64862	Balance/cognitive function analysis system	An assembly of devices intended to provide interactive tests for a patient in a clinical setting to assess balance and cognitive status (e.g., attention, concentration, short term memory/recall, motor control). It consists of an electronic floor plate sensor to measure balance deficits, hand controllers (e.g., videogame-like joystick, keyboard) for interactive on-screen tests, and a tablet/software to provide cognitive/motion control tests and comparative assessment results. This device is typically used to screen for and/or monitor patients at risk of fall, who suffered a concussion, or who are affected by dementia or neuromuscular disorders (e.g., Alzheimer’s disease, Parkinson’s disease).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXV	Apparatus, Vestibular Analysis

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45ff45b9-4234-4c22-8120-a11aa74d4544
Public Version Date: August 08, 2023
Public Version Number: 1
DI Record Publish Date: July 31, 2023