DeviceClearance

Product code IMA— Physical Medicine

HEAT PACK

Classification name
Pack, Heat, Moist
Device class
Class 1
Regulation
21 CFR 890.5730
Advisory panel
Physical Medicine
Total cleared
8
First cleared
Most recent

Market context for product code IMA

FDA has cleared 8 devices under product code IMA between 1979 and 2015, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code IMA

Recent clearances under product code IMA

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