DeviceClearance

Product code IMD— Physical Medicine

EYEFEEL OPHTHALMIC WARMER

Classification name
Pack, Hot Or Cold, Disposable
Device class
Class 1
Regulation
21 CFR 890.5710
Advisory panel
Physical Medicine
Total cleared
82
First cleared
Most recent

Market context for product code IMD

FDA has cleared 82 devices under product code IMD between 1976 and 2022, filed by 61 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

last 15 years

Top applicants under product code IMD

Adverse events under product code IMD

product code IMD
Death
3
Injury
600
Total
603

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 IMD

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