DeviceClearance

Product code HJG— Ophthalmic

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE

Classification name
System, Reading, Television, Closed-Circuit
Device class
Class 1
Regulation
21 CFR 886.5820
Advisory panel
Ophthalmic
Total cleared
8
First cleared
Most recent

Market context for product code HJG

FDA has cleared 8 devices under product code HJG between 1989 and 1994, filed by 4 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 HJG

Recent clearances under product code HJG

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