Koresway

GUDID 00008600088282

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.

Diversified Healthcare Development, LLC

Balance/cognitive function analysis system

• Primary Device ID: 00008600088282
• NIH Device Record Key: c9f63b03-46fb-4ce6-ba95-bea0bfdd249f
• Commercial Distribution Discontinuation: 2028-08-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koresway
• Version Model Number: KB05
• Company DUNS: 048174391
• Company Name: Diversified Healthcare Development, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00008600088282 [Primary]

FDA Product Code

• KHX: Platform, Force-Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-30
• Device Publish Date: 2023-08-22

Devices Manufactured by Diversified Healthcare Development, LLC

• 00008600088282 - Koresway: 2023-08-30The 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.
• 00008600088282 - Koresway: 2023-08-30 The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable packag
• 00858458007009 - Korebalance Premiere: 2023-08-08 The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreat