FDA UDI
In Commercial Distribution
🇺🇸 United States
Myocene
DI: 05430004268000
·
Model: 1-U
·
Myocene
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Myocene
- Primary DI
- 05430004268000
- Version / Model
- 1-U
- Company Name
- Myocene
- Labeler DUNS
- 372401437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-17
- Public Version
- 1
- Public Version Date
- 2025-04-25
- Public Version Status
- New
- Public Device Record Key
- aafa7bd6-830a-4cae-a934-4e8678894c26
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SDX | Neuromuscular Stimulator And Exercise Evaluation System | Neurology | 882.1871 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67508 | Quadriceps fatigue electrostimulation analyser | An 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05430004268000 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 95 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal