BrainPort

Primary DI
00862378000347
Brand
BrainPort
Company
WICAB, INC
Model
Vision Pro
Catalog number
DR-001416
Device 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.
Published
2018-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PICOral Electronic Vision Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PICOral Electronic Vision AidOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862378000347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862378000347008623780003478623780003470862378000347

GMDN Terms#

Term, Definition table
TermDefinition
Video-camera translingual electrical stimulation systemAn assembly of devices designed to assist a blind person in orientation, mobility, and object recognition by capturing video images and translating them into electrical stimuli which are applied to the tongue. It consists of a pair of dedicated video-camera spectacles, a controller, and an electrode array intended to be placed on the tongue. With training, the device is intended to enable users to interpret the shape, size, location and motion of objects in their environment as an adjunct to other assistive devices (e.g., guide dog, cane). This is a single-patient, reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
608-829-4500customersupportus@wicab.com

Regulatory Flags#

DUNS number
158610712
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862378000309BrainPortV100DR-0010622017-08-11
00862378000316BrainPortVision ProDR-0014132018-03-20
00862378000323BrainPortVision ProDR-0014142018-03-20
00862378000330BrainPortVision ProDR-0014152018-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00862378000316BrainPortWICAB, INCPIC2018-03-20
00862378000323BrainPortWICAB, INCPIC2018-03-20
00862378000330BrainPortWICAB, INCPIC2018-03-20
00862378000309BrainPortWICAB, INCPIC2017-08-11