BrainPort

WICAB, INC · Model Vision Pro · UDI-DI 00862378000347

PIC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The BrainPort Vision Pro is an oral electronic vision aid that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog. It translates digital information from a video camera to gentle electrical stimulation patterns on the surface of the tongue.

Recalls

Date	Firm	Reason
2019-01-14	Becton Dickinson & Co.	False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets o

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.