De Novo DEN230051

Device: Myocene
Contact: jean-yves mignolet
De Novo number: DEN230051
Product code: SDX
Regulation: 882.1871
Classification name: neuromuscular stimulator and exercise evaluation system
Decision: granted (DENG)
Decision date: 2025-01-17
Date received: 2023-07-27
Classification advisory: Neurology
Review advisory: Physical Medicine
Type: Direct

Current FDA Classification#

Product code: SDX
Device name: Neuromuscular Stimulator And Exercise Evaluation System
Medical specialty: Neurology
Device class: 2
Regulation: 882.1871
Implant: N
Life sustain/support: N