DeviceClearance

Product code IRN— Physical Medicine

ACCUTRED SHOE

Classification name
Device, Warning, Overload, External Limb, Powered
Device class
Class 2
Regulation
21 CFR 890.5575
Advisory panel
Physical Medicine
Total cleared
11
First cleared
Most recent

Market context for product code IRN

FDA has cleared 11 devices under product code IRN between 1977 and 2006, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code IRN

Recent clearances under product code IRN

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