ISEN-Goggles

Primary DI
B499V060
Brand
ISEN-Goggles
Company
ISEN Tech. & Trading Co., Ltd.
Model
V06
Device description
The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152727000ISEN-GogglesIsen Tech & Trading Company, Ltd.2016-04-26GWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B499V061PackageHIBCC1In Commercial Distribution
B499V062PackageHIBCC1In Commercial Distribution
B499V060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nystagmus inducing optokinetic drumA drum-like ophthalmic device covered with alternating white and dark stripes or pictures. The device is rotated in front of the patient's eyes and is intended to elicit nystagmus (involuntary rapid movement of the eyeball). This is used to diagnose the patient and is particularly useful for babies and children who cannot communicate, e.g., if nystagmus cannot be induced, this suggests that the child suffers from impaired vision or blindness.

Contacts#

Phone, Email table
PhoneEmail
954-591-9309sliu@colandmedical.com

Regulatory Flags#

DUNS number
527141254
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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