# K152851: BrainPort V100

- Pathway: 510(k) (Traditional)
- Applicant: Wicab, Inc.
- Decided: Dec 24, 2015 after 86 days
- Product code: PIC (Oral Electronic Vision Aid)
- Device class: 2
- Regulation: 21 CFR 886.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130039 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130039: Brainport V100 Device, Wicab, Inc. (2015) Summary page 4.

## Indications for use
The BrainPort V100 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.

Source page: https://510kreport.com/device/K152851
Methodology: https://510kreport.com/methodology