AccessGUDID - DEVICE: Koresway (00008600088282)

GUDID

Device Identifier (DI) Information

Brand Name: Koresway
Version or Model: KB05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diversified Healthcare Development, LLC

Primary DI Number: 00008600088282
Issuing Agency: GS1
Commercial Distribution End Date: August 22, 2028
Device Count: 1
Labeler D-U-N-S® Number*: 048174391 *Terms of Use

Device Description: The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable package. Utilizing proven force transducers and rapid sampling rates, the KoreSway™ captures the minute patient center of gravity movements. Includes a portable safety rail system with integrated wheels that fits through standard-size doorways.

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
KHX	Platform, Force-Measuring

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9f63b03-46fb-4ce6-ba95-bea0bfdd249f
Public Version Date: August 30, 2023
Public Version Number: 1
DI Record Publish Date: August 22, 2023