Product code ITN— Physical Medicine

COUNTER-ROTATION SYSTEM

Classification name
Splint, Denis Brown
Device class
Class 1
Regulation
21 CFR 890.3675
Advisory panel
Physical Medicine
Total cleared
3
First cleared
Most recent

Market context for product code ITN

FDA has cleared 3 devices under product code ITN between 1982 and 2007, filed by 3 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 ITN

Recent clearances under product code ITN

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