FDA.reportPublic FDA data

DIERS myoline

Primary DI
04260242060118
Brand
DIERS myoline
Company
DIERS International GmbH
Model
professional
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
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260242060118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260242060118042602420601184260242060118

GMDN Terms#

Term, Definition table
TermDefinition
MyographA mains electricity (AC-powered) device designed for determining and recording the different phases of the intensity or velocity of a muscular contraction. It includes a sensor for detecting the displacement and/or force related to the muscle contraction and reproducing them in a graph (myogram). A myograph is used in the evaluation of muscles in several conditions, e.g., displacement under constant tension or force exerted under an isometric condition.

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
04260242060125DIERS leg axis lateraln/a2023-06-02
04260242060132DIERS pedogaitn/a2023-06-02
04260242060163DIERS leg axisHP2023-06-02
04260242060170DIERS leg axis lateralHP2023-06-02
04260242060194DIERS posturan/a2023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649998859011NUSHUMagnes AGJFC2026-05-31
07649998859028NUSHUMagnes AGJFC2026-05-31
07649998859035NUSHUMagnes AGJFC2026-05-31
04260242060217DIERS pedoscanDIERS International GmbHJFC2026-03-09
05425026002008Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002015Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002046Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002053Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05391550080006Danu DANU SPORTS LIMITEDJFC2025-12-17
06941691920540Orantech Orantech Inc.JFC2024-12-17
06941691921134Orantech Orantech Inc.JFC2024-12-17
06941691909620Orantech Orantech Inc.JFC2024-12-05
06941691909736Orantech Orantech Inc.JFC2024-12-05
06941691910022Orantech Orantech Inc.JFC2024-12-05
06941691910619Orantech Orantech Inc.JFC2024-12-05
06941691910688Orantech Orantech Inc.JFC2024-12-05
03760349820055FeetMe Monitor FTM-DKFEETMEJFC2023-03-24
07540150603308BodiTrakVista Medical LtdJFC2022-12-13
07540150603780BodiTrakVista Medical LtdJFC2022-12-13
03760349820048FeetMe Monitor FTM-DKFEETMEJFC2022-11-11
B970303012503030-125 SensorTekscan, Inc.JFC2020-11-04
B9703000E12503000-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000E5003000-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000ES03000-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTES03000SPORT-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001E12503001-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001ES03001-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001SPORTE12503001SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03