Myocene

Primary DI
05430004268000
Brand
Myocene
Company
Myocene
Model
1-U
Device description
The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
SDXNeuromuscular Stimulator And Exercise Evaluation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDXNeuromuscular Stimulator And Exercise Evaluation SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430004268000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430004268000054300042680005430004268000

GMDN Terms#

Term, Definition table
TermDefinition
Quadriceps fatigue electrostimulation analyserAn electrically-powered device intended to measure muscle fatigue of the quadriceps based on the force of muscle contraction under: 1) noninvasive electrical stimulation at different electrical impluse frequencies (long-term peripheral muscle fatigue); and 2) voluntary exertion before and after exercise (global muscle fatigue). It is in the form of a seat unit with an integrated electrical stimulator, a shin rest with an integrated dynamometer (force sensor), and electrode leads/cables connection points. Muscle fatigue data is typically based on the ratio of force output under different conditions and is analysed and viewed on a connected off-the-shelf computer (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature23 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
372401437
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430004268017Myocene Electrode12025-04-24