DeviceClearance

Product code IRP— Physical Medicine

Therm-X

Classification name
Massager, Powered Inflatable Tube
Device class
Class 2
Regulation
21 CFR 890.5650
Advisory panel
Physical Medicine
Total cleared
156
First cleared
Most recent

Market context for product code IRP

FDA has cleared 156 devices under product code IRP between 1978 and 2026, filed by 97 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code IRP

Recent clearances under product code IRP

1–100 of 156

Data sourced from openFDA. This site is unofficial and independent of the FDA.