FDA Product Code IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Leading manufacturers include BTL Industries, Inc., Shenzhen Dongdixin Technology Co., Ltd. and Xemis Medical Technology (Shenzhen) Co., Ltd..
FDA 510(k) Cleared Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Devices (Product Code IMG)
About Product Code IMG - Regulatory Context
510(k) Submission Activity
55 total 510(k) submissions under product code IMG since 1977, with 55 receiving FDA clearance (average review time: 151 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.
FDA Review Time
Recent submissions under IMG have taken an average of 281 days to reach a decision - up from 148 days historically. Manufacturers should account for longer review timelines in current project planning.
IMG devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →