Koresway

Primary DI
00008600088282
Brand
Koresway
Company
Diversified Healthcare Development, LLC
Model
KB05
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 patientcenter of gravity movements. Includes a portable safety rail system with integrated wheels that fits through standard-size doorways.
Published
2023-08-22
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
KHXPlatform, Force-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHXPlatform, Force-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00008600088282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00008600088282000086000882820086000882820008600088282

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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858458007870Korebalance MobileKB05B2026-04-21
00858458007009Korebalance PremiereKB012023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908024776005EQUIPOISEEQUIDOR MEDTECH LLPKHX2025-02-19
03770011995387KForce PlatesKINVENT BIOMECANIQUEKHX2024-01-03
03770011995417KForce DeltasKINVENT BIOMECANIQUEKHX2024-01-03
03770011995608KForce Deltas XLKINVENT BIOMECANIQUEKHX2024-01-03
B915012430050FDM-SXzebris MEDICAL GmbHKHX2023-08-11
B915012430100FDM-Szebris MEDICAL GmbHKHX2023-08-11
B915012430150FDM-1.5zebris MEDICAL GmbHKHX2023-08-11
B915012430200FDM-2zebris MEDICAL GmbHKHX2023-08-11
B915012430300FDM-3zebris MEDICAL GmbHKHX2023-08-11
B915015430051FDM-SX Systemzebris MEDICAL GmbHKHX2023-08-11
B915015430101FDM-S Systemzebris MEDICAL GmbHKHX2023-08-11
B915015430151FDM-1.5 Systemzebris MEDICAL GmbHKHX2023-08-11
B915015430201FDM-2 Systemzebris MEDICAL GmbHKHX2023-08-11
B915015430301FDM-3 Systemzebris MEDICAL GmbHKHX2023-08-11
00718175004302VibroTactileSPORT MEDICAL TECHNOLOGY INC.KHX2023-07-19
B435MT07MotionTrakWESTERN SYSTEMS RESEARCH INC.KHX2023-06-27
04260242060132DIERS pedogaitDIERS International GmbHKHX2023-06-02
04900070930664MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
24900070937414MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
24900070937421MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
04900070942322MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
24900070945112MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
24900070945129MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
24900070945211MOLDCARE RI IIALCARE CO., LTD.KHX2023-04-16
00860010129104BTrackS Balance PlateBalance Tracking Systems IncorporatedKHX2023-03-30
00860010129111Assess Balance Balance Tracking Systems IncorporatedKHX2023-03-30
00850017250116Bertec Head Mounted Display System (HMD)BERTEC CORPORATIONKHX2023-02-08
24900070938220MOLDCARE RI IIALCARE CO., LTD.KHX2022-11-25
04900070938219MOLDCARE RI IIALCARE CO., LTD.KHX2022-11-22
03760310780555StaticVRVIRTUALISKHX2021-12-09