FDA Product Code IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Leading manufacturers include Manamed, Inc., Shenzhen Dongdixin Technology Co., Ltd. and Enraf-Nonius, B.V..
FDA 510(k) Cleared Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Devices (Product Code IMI)
About Product Code IMI - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code IMI since 1978, with 89 receiving FDA clearance (average review time: 156 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under IMI have taken an average of 439 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
IMI devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →