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 Code | PIC |
Premarket Review |
Office of 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 Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|