Product code IRA— Physical Medicine

PREHENSILE HAND

Classification name
Hand, External Limb Component, Mechanical
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 IRA

FDA has cleared 2 devices under product code IRA between 1979 and 1982, filed by 1 applicant company. 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 IRA

Recent clearances under product code IRA

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