FDA.reportPublic FDA data

DIERS leg axis lateral

Primary DI
04260242060170
Brand
DIERS leg axis lateral
Company
DIERS International GmbH
Model
HP
Published
2023-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260242060170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260242060170042602420601704260242060170

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis system, motion-trackingA mains electricity (AC-powered) device assembly designed to track and evaluate the movement of the human body or body segments for the purpose of obtaining graphical visualization and biomechanical analysis of the body (e.g., spinal or joint movements). The device can also be used to determine the extent of ataxia (failure of muscular coordination) and will typically be used in the study of sports/work/rehabilitation related mechanisms/tasks; it is not dedicated to gait analysis alone. It may include various components to achieve its purpose [e.g., markers, sensors, video cameras, image processors, and computers].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
499189983
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260242060200DIERS iEMGn/a2026-03-09
04260242060217DIERS pedoscan0.42026-03-09
04260242060316DIERS free²moven/a2026-03-09
04260242060019DIERS formetricIII 4D2023-06-02
04260242060064DIERS leg axisn/a2023-06-02
04260242060071DIERS pedoscan0.52023-06-02
04260242060101DIERS staticoII2023-06-02
04260242060118DIERS myolineprofessional2023-06-02
04260242060125DIERS leg axis lateraln/a2023-06-02
04260242060132DIERS pedogaitn/a2023-06-02
04260242060163DIERS leg axisHP2023-06-02
04260242060194DIERS posturan/a2023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021091UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021107UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021114UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021121UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021138UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.KQX2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.KQX2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.KQX2025-10-23
00850004866184ActivForce 2ActivBody, Inc.KQX2025-09-03
05694230564002NeckCare AssessmentsNeckCare Holding ehfKQX2025-05-30
05694230564033NeckCare DeviceNeckCare Holding ehfKQX2025-05-30
09413000126259myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000126273myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000123395Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
09413000123418Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCKQX2024-09-03