FDA Product Code SDO: Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit.
Leading manufacturers include Onward Medical, Inc., Aneuvo and Spinex, Inc..
FDA 510(k) Cleared Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Devices (Product Code SDO)
About Product Code SDO - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code SDO since 2024, with 3 receiving FDA clearance (average review time: 192 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SDO devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →