Current through November 30, 2024
Section 886.5900 - Electronic vision aid(a)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.(b)Classification. 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 .55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814 , July 25, 2001