Korebalance Premiere

GUDID 00858458007009

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.

Diversified Healthcare Development, LLC

Balance/cognitive function analysis system

• Primary Device ID: 00858458007009
• NIH Device Record Key: 45ff45b9-4234-4c22-8120-a11aa74d4544
• Commercial Distribution Discontinuation: 2027-07-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Korebalance Premiere
• Version Model Number: KB01
• Company DUNS: 048174391
• Company Name: Diversified Healthcare Development, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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
• Phone: 800-831-7665
• Email: info@medicalfitsolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858458007009 [Primary]

FDA Product Code

• LXV: Apparatus, Vestibular Analysis

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: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by Diversified Healthcare Development, LLC

• 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: 2023-08-08The 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.
• 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