Korebalance Mobile

Primary DI
00858458007870
Brand
Korebalance Mobile
Company
Diversified Healthcare Development, LLC
Model
KB05B
Device description
The Korebalance® Mobile 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.
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXVApparatus, Vestibular Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXVApparatus, Vestibular AnalysisUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858458007870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858458007870008584580078708584580078700858458007870

GMDN Terms#

Term, Definition table
TermDefinition
Balance/cognitive function analysis systemAn 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).

Contacts#

Phone, Email table
PhoneEmail
800-831-7665info@medicalfitsolutions.com
760-451-9162support@medicalfitsolutions.com

Regulatory Flags#

DUNS number
048174391
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00008600088282KoreswayKB052023-08-22
00858458007009Korebalance PremiereKB012023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00868168000306SwayHEALTHY ROSTER LLCLXV2026-04-13
00199874750514K-D BalanceKing-Devick Test, Inc.LXV2026-03-03
00858458007009Korebalance PremiereDiversified Healthcare Development, LLCLXV2023-07-31
05711117219098InteracousticsInteracoustics A/SLXV2020-05-29