HPF · Aid, Vision, Electronic, Ac-Powered
Ophthalmic · 21 CFR 886.5900 · Class 1
Overview
| Product Code | HPF |
|---|---|
| Device Name | Aid, Vision, Electronic, Ac-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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863993 | VTS REPORTER OR VTS LINK | Sensory Aids Corp. | Oct 31, 1986 | SESE |
Top Applicants
- Sensory Aids Corp. — 1 clearance
