AccessGUDID - DEVICE: ISEN-Goggles (B499V060)

GUDID

Device Identifier (DI) Information

Brand Name: ISEN-Goggles
Version or Model: V06
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ISEN Tech. & Trading Co.,Ltd.

Primary DI Number: B499V060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 527141254 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16476	Nystagmus inducing optokinetic drum	A 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.	Active	false
32706	Nystagmus inducing tape	An ophthalmic device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWN	Nystagmograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152727	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 322563a2-dbd7-4eec-b362-86b550f25654
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2017