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510(k) Data Aggregation

    K Number
    K152851
    Device Name
    BrainPort V100
    Manufacturer
    WICAB, INC.
    Date Cleared
    2015-12-24

    (86 days)

    Product Code
    PIC
    Regulation Number
    886.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    WICAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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.
    Device Description
    The BrainPort V100 design and components are the same as the previously granted BrainPort V100; the device continues to consist of the headset, controller (handset), intra-oral device (IOD), and battery charger. The camera unit in the headset captures the viewed scene as a digital image and forwards that image to the controller for processing. The IOD presents stimulation patterns representative of the camera image to the user's tongue. Same as in DEN130039, the BrainPort V100 is a fully wearable, battery operated device with no physical connections to external equipment during normal operation. The device includes a means for a sighted individual (e.g., instructor) to remotely view the camera and IOD images to assist in training through its vRemote software program.
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