DeviceClearance

Product code IQI— Physical Medicine

ACCUFLEX DYNAMIC ELBOW ORTHOSIS

Classification name
Orthosis, Limb Brace
Device class
Class 1
Regulation
21 CFR 890.3475
Advisory panel
Physical Medicine
Total cleared
52
First cleared
Most recent

Market context for product code IQI

FDA has cleared 52 devices under product code IQI between 1976 and 2015, filed by 34 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 IQI

Recent clearances under product code IQI

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