LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE
Device Facts
| Record ID | K933633 |
|---|---|
| Device Name | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE |
| Applicant | Gracefully Yours, Inc. |
| Product Code | HJG · Ophthalmic |
| Decision Date | Feb 22, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5820 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.
