FDA Product Code IRP: Massager, Powered Inflatable Tube

510(k) Submission Activity

150 total 510(k) submissions under product code IRP since 1978, with 150 receiving FDA clearance (average review time: 153 days).

Submission volume has increased in recent years - 26 submissions in the last 24 months compared to 21 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for IRP submissions have been consistent, averaging 163 days recently vs 151 days historically.