Koresway

Basic Information

• Brand Name: Koresway
• Primary DI: 00008600088282
• Version / Model: KB05
• Company Name: Diversified Healthcare Development, LLC
• Labeler DUNS: 048174391
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-22
• Public Version: 1
• Public Version Date: 2023-08-30
• Public Version Status: New
• Public Device Record Key: c9f63b03-46fb-4ce6-ba95-bea0bfdd249f
• Distribution End Date: 2028-08-22

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

• 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: No
• 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
KHX	Platform, Force-Measuring	Physical Medicine	890.1575	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00008600088282	GS1

Customer Contacts

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