FDA Product Code ITH: Equipment, Traction, Powered
Leading manufacturers include Excite Medical of Tampa Bay, LLC, Ergo-Flex Technologies, LLC and Zimmer Medizinsysteme GmbH.
FDA 510(k) Cleared Equipment, Traction, Powered Devices (Product Code ITH)
About Product Code ITH - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code ITH since 1977, with 71 receiving FDA clearance (average review time: 133 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under ITH have taken an average of 227 days to reach a decision - up from 130 days historically. Manufacturers should account for longer review timelines in current project planning.
ITH devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →