FDA Product Code IRT: Pad, Heating, Powered
Leading manufacturers include mibeTec GmbH.
FDA 510(k) Cleared Pad, Heating, Powered Devices (Product Code IRT)
About Product Code IRT - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code IRT since 1977, with 42 receiving FDA clearance (average review time: 177 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under IRT have taken an average of 245 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.
IRT devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →