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U.S. Department of Health and Human Services

Product Classification

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Device oral electronic vision aid
Regulation Description Oral electronic vision aid.
Definition To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)
Physical State headset (camera, glasses), intra-oral electrode array, battery, cable, software package
Technical Method Translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue.
Target Area tongue, eyes
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePIC
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5905
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible