# DEN130039: Brainport V100 Device

- Pathway: De Novo (Direct)
- Applicant: Wicab, Inc.
- Decided: Jun 18, 2015 after 680 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K152851: BrainPort V100 (2015), 0 descendants of its own

## Indications for use
The BrainPort V100, a prescription device under 21 CFR Part 801.109 that is indicated for use as 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/DEN130039
Methodology: https://510kreport.com/methodology