DeviceClearance

Product code IME— Physical Medicine

ACE COLD BANDAGE

Classification name
Pack, Hot Or Cold, Reusable
Device class
Class 1
Regulation
21 CFR 890.5700
Advisory panel
Physical Medicine
Total cleared
27
First cleared
Most recent

Market context for product code IME

FDA has cleared 27 devices under product code IME between 1977 and 1993, filed by 24 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 IME

Adverse events under product code IME

product code IME
Other
1
Total
1

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 IME

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