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.
1
Total
0
Cleared
540d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Neuromuscular Stimulator And Exercise Evaluation System Devices (Product Code SDX)
1 devices
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.