510(k) DEN230051

Myocene by Myocene — Product Code SDX

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 17, 2025
Date Received: July 27, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Neuromuscular Stimulator And Exercise Evaluation System
Device Class: Class II
Regulation Number: 882.1871
Review Panel: NE
Submission Type

A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions.