Cleared Traditional

K933633 - LOW-VISION READING AID

K933633 is an FDA 510(k) clearance for LOW-VISION READING AID, manufactured by Gracefully Yours, Inc.. The device is a Class 1 Ophthalmic device with product code HJG cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K933633 · Gracefully Yours, Inc. · Ophthalmic device
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Feb 1994
Decision
210d
Days
Class 1
Risk

K933633 is an FDA 510(k) clearance for the LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE. Classified as System, Reading, Television, Closed-circuit (product code HJG), Class I - General Controls.

Submitted by Gracefully Yours, Inc. (Largo, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 210 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5820 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Gracefully Yours, Inc. devices

FDA 510(k) Submission Details - K933633

510(k) Number K933633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date February 22, 1994
Days to Decision 210 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 110d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

HJG Device Classification - Class 1, General Controls

Product Code HJG System, Reading, Television, Closed-circuit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.