FDA.reportPublic FDA data

KForce Deltas

Primary DI
03770011995417
Brand
KForce Deltas
Company
KINVENT BIOMECANIQUE
Model
K Deltas V3
Device description
K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
Published
2024-01-03
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
03770011995417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770011995417037700119954173770011995417

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis system, force-testing, portableA portable computerized device assembly with multiple force-sensing hardware designed for analysis of biomechanical/neuromuscular function by enabling performance of: 1) multiple functional strength tests using a variety of hardware (e.g., dynamometers, pinchmeters); or 2) strength testing with additional neuromuscular function testing (range of motion or pain/touch sensitivity) using additional hardware (e.g., goniometer, algometer). The system is typically designed so results can be displayed on an off-the-shelf computer/smartphone. It is not intended for interactive gaming and is not primarily based on analysing movement through motion sensing (i.e., not a kinesiology system).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33467130033info@k-invent.com

Regulatory Flags#

DUNS number
269560516
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770011995707K MyoK Myo V32024-01-05
03770011995875K MyoK Myo Black V32024-01-05
03770011995370KForce Muscle ControllerK Push V32024-01-03
03770011995387KForce PlatesK Force Plates V32024-01-03
03770011995424KForce LinkK Pull V32024-01-03
03770011995431KForce GripK Grip V32024-01-03
03770011995455KForce BubbleK Bubble V32024-01-03
03770011995462KForce SensK Move V32024-01-03
03770011995608KForce Deltas XLK Deltas XL V32024-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908024776005EQUIPOISEEQUIDOR MEDTECH LLPKHX2025-02-19
03770011995387KForce PlatesKINVENT 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
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