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510(k) Data Aggregation
K Number
K152851Device Name
BrainPort V100
Manufacturer
WICAB, INC.
Date Cleared
2015-12-24
(86 days)
Product Code
PIC
Regulation Number
886.5905Why 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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K Number
DEN130039Device Name
BRAINPORT V100 DEVICE
Manufacturer
WICAB, INC
Date Cleared
2015-06-18
(680 days)
Product Code
PIC
Regulation Number
886.5905Why 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 is an electronic assistive aid that translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue. With training, users are able to use the electrotactile signals to perceive shape, size, location and motion of objects. The BrainPort V100 is intended to augment, rather than replace, other assistive technology such as the white cane or guide dog. The BrainPort V100 is not used to diagnose or treat the underlying condition that leads to the user's visual impairment. The BrainPort V100 is intended for prescription use only and for single patient use. The BrainPort V 100 consists of three components: the headset, the controller (also known as the handset), and the battery charger.
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