DeviceClearance

Product code IRT— Physical Medicine

ARTHRITIC HEAT WRAP

Classification name
Pad, Heating, Powered
Device class
Class 2
Regulation
21 CFR 890.5740
Advisory panel
Physical Medicine
Total cleared
42
First cleared
Most recent

Market context for product code IRT

FDA has cleared 42 devices under product code IRT between 1977 and 2025, filed by 33 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 IRT

Adverse events under product code IRT

product code IRT
Injury
668
Total
668

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code IRT

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