Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5900](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5900) → HPF — Aid, Vision, Electronic, Ac-Powered

# HPF · Aid, Vision, Electronic, Ac-Powered

_Ophthalmic · 21 CFR 886.5900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPF

## Overview

- **Product Code:** HPF
- **Device Name:** Aid, Vision, Electronic, Ac-Powered
- **Regulation:** [21 CFR 886.5900](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5900)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPF/K863993.md) | VTS REPORTER OR VTS LINK | Sensory Aids Corp. | Oct 31, 1986 | SESE |

## Top Applicants

- Sensory Aids Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPF](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPF)

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