Cleared Traditional

K933633 - LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE (FDA 510(k) Clearance)

K933633 · Gracefully Yours, Inc. · Ophthalmic device

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. This device is classified as a System, Reading, Television, Closed-circuit (Class I - General Controls, product code HJG).

Submitted by Gracefully Yours, Inc. (Largo, US). The FDA issued a Cleared decision on February 22, 1994, 210 days after receiving the submission on July 27, 1993.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5820.

Submission Details

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