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 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
- 2007
- 2003
- 1982
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.