21 CFR 886.5900 — Aid, Vision, Electronic, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5900

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HPFAid, Vision, Electronic, Ac-Powered11
HPGAid, Vision, Electronic, Battery-Powered17
Innolitics

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