BrainPort

WICAB, INC · Model V100 · UDI-DI 00862378000309

PIC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The BrainPort® V100 is an oral electronic vision aid that provides electrotactile 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.