FDA.reportPublic FDA data

FDM-3 System

Primary DI
B915015430301
Brand
FDM-3 System
Company
zebris MEDICAL GmbH
Model
01543030
Catalog number
NA
Device description
Platform system for pressure distribution measurement under the human feet, intended for the analysis of the static and dynamic loads, as well as the individual gait parameters.
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B915015430301PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gait analysis systemAn assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-364-8985support@noraxon.com

Regulatory Flags#

DUNS number
328971791
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
B915015705201Inductive Charger Tizian JMA-Optic01570520NA2023-10-04
B915015705401Inductive Charger ARCUSdigma III01570540NA2023-10-04
B915011700230Tizian JMA Optic USB01170023NA2023-07-20
B915011700410ARCUSdigma 3 USB01170041NA2023-07-20
B915015700231Tizian JMA Optic USB01570023NA2023-07-20
B915015700411ARCUSdigma 3 USB01570041NA2023-07-20
B915011700210Tizian JMA Optic01170021NA2021-02-18
B915011700400ARCUSdigma 301170040NA2021-02-18
B915015700211Tizian JMA Optic01570021NA2021-02-18
B915015700401ARCUSdigma 301570040NA2021-02-18
B915015705101Inductive Charger JMA-Optic01570510NA2023-10-04
B915015705501Inductive Charger zebris for ceramill01570550NA2023-10-04
B915015705701Inductive Charger PlaneAnalyser II01570570NA2023-10-04
B915012430050FDM-SX01243005NA2023-08-11
B915012430100FDM-S01243010NA2023-08-11
B915012430150FDM-1.501243015NA2023-08-11
B915012430200FDM-201243020NA2023-08-11
B915012430300FDM-301243030NA2023-08-11
B915015430051FDM-SX System01543005NA2023-08-11
B915015430101FDM-S System01543010NA2023-08-11

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
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