DeviceClearance

Product code ION— Physical Medicine

NON-MEASURING EXERCISERS

Classification name
Exerciser, Non-Measuring
Device class
Class 1
Regulation
21 CFR 890.5370
Advisory panel
Physical Medicine
Total cleared
43
First cleared
Most recent

Market context for product code ION

FDA has cleared 43 devices under product code ION between 1976 and 2012, filed by 18 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 ION

Recent clearances under product code ION

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