FDA Product Code SGT: Electromagnetic Stimulator For Healthy Muscle Stimulation
A Device Used For Other Than Medical Purposes To Induce An Electrical Current To The Body Using A Time-varying Magnetic Field To Temporarily Increase Local Blood Flow And Stimulate Healthy Muscles. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions.
Leading manufacturers include Aura Wellness, LLC.
FDA 510(k) Cleared Electromagnetic Stimulator For Healthy Muscle Stimulation Devices (Product Code SGT)
About Product Code SGT - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGT since 2025, with 1 receiving FDA clearance (average review time: 252 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.
SGT devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →