DeviceClearance

Product code IQE— Physical Medicine

TRUNCAL ORTHOSIS

Classification name
Orthosis, Lumbar
Device class
Class 1
Regulation
21 CFR 890.3490
Advisory panel
Physical Medicine
Total cleared
4
First cleared
Most recent

Market context for product code IQE

FDA has cleared 4 devices under product code IQE between 1981 and 1982, filed by 4 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 IQE

Recent clearances under product code IQE

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