510(k) K933633

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE by Gracefully Yours, Inc. — Product Code HJG

K933633 is an FDA 510(k) premarket notification submitted by Gracefully Yours, Inc. for the device "LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code HJG (System, Reading, Television, Closed-Circuit), a Class I device regulated under 21 CFR 886.5820. Gracefully Yours, Inc. has at least 1 other 510(k) clearance on record.