FDA Product Code SDX: Neuromuscular Stimulator And Exercise Evaluation System
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.
Leading manufacturers include Myocene.
FDA 510(k) Cleared Neuromuscular Stimulator And Exercise Evaluation System Devices (Product Code SDX)
About Product Code SDX - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SDX since 2025, with 0 receiving FDA clearance (average review time: 540 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SDX devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →