DeviceClearance

Product code IRO— Physical Medicine

A013 FEMI-FORM FACIAL MASSAGER

Classification name
Vibrator, Therapeutic
Device class
Class 1
Regulation
21 CFR 890.5975
Advisory panel
Physical Medicine
Total cleared
65
First cleared
Most recent

Market context for product code IRO

FDA has cleared 65 devices under product code IRO between 1976 and 1996, filed by 35 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

last 15 years

Top applicants under product code IRO

Recent clearances under product code IRO

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