FDA Product Code IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Leading manufacturers include Viatherm Therapeutics, LLC, BTL Industries, Inc. and Regenesis Biomedical, Inc..
FDA 510(k) Cleared Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Devices (Product Code IMJ)
About Product Code IMJ - Regulatory Context
510(k) Submission Activity
44 total 510(k) submissions under product code IMJ since 1977, with 44 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under IMJ have taken an average of 268 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
IMJ devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →