FDA.reportPublic FDA data

Assess Balance

Primary DI
00860010129111
Brand
Assess Balance
Company
Balance Tracking Systems Incorporated
Model
Version 7
Published
2023-03-30
Public version status
Update
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
00860010129111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010129111008600101291118600101291110860010129111

GMDN Terms#

Term, Definition table
TermDefinition
Posturography system application softwareAn application software program designed for use in, or together with, a balance/mobility management system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-811-0054andy@balancetrackingsystems.com

Regulatory Flags#

DUNS number
079365006
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010129104BTrackS Balance PlateBTRACKS-502023-03-30

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
00008600088282KoreswayDiversified Healthcare Development, LLCKHX2023-08-22
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
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