Product code IRE— Physical Medicine
ELBOW PROSTHESIS
- Classification name
- Joint, Elbow, External Limb Component, Powered
- Device class
- Class 1
- Regulation
- 21 CFR 890.3420
- Advisory panel
- Physical Medicine
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code IRE
FDA has cleared devices under product code IRE between 1980 and 1982, filed by 2 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
- 1982
- 1980
Top applicants under product code IRE
Recent clearances under product code IRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.