HPG · Aid, Vision, Electronic, Battery-Powered
Ophthalmic · 21 CFR 886.5900 · Class 1
Overview
| Product Code | HPG |
|---|---|
| Device Name | Aid, Vision, Electronic, Battery-Powered |
| Regulation | 21 CFR 886.5900 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910601 | PATHFINDER | Nurion Industries | May 14, 1991 | SESE |
| K910124 | LOW VISION ENHANCEMENT SYSTEM (LVES) | Triangle Investments | Apr 10, 1991 | SESE |
| K903558 | LASER CANE | Nurion Industries | Sep 27, 1990 | SESE |
| K902187 | POLARON | Nurion Industries | Aug 8, 1990 | SESE |
| K862338 | SENSORY 6 | Brytech, Inc. | Sep 3, 1986 | SESE |
| K823385 | ALES | Oms | Mar 9, 1983 | SESE |
| K761215 | F4912 NIGHT VISION AID | Itt Corp. | Dec 16, 1976 | SESE |
Top Applicants
- Nurion Industries — 3 clearances
- Triangle Investments — 1 clearance
- Oms — 1 clearance
- Itt Corp. — 1 clearance
- Brytech, Inc. — 1 clearance
