# DEN230051: Myocene

- Pathway: De Novo (Direct)
- Applicant: Myocene
- Decided: Jan 17, 2025 after 540 days
- Product code: SDX (Neuromuscular Stimulator And Exercise Evaluation System)
- Device class: 2
- Regulation: 21 CFR 882.1871
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN230051
Methodology: https://510kreport.com/methodology