Vestibular First, LLC

Address:9 Mather Ave,Broomall,PA,19008,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Nystagmograph (GWN) (2)

Premarket Exempt

Clear

Vestibular First - 00860002280707 Catalog Number :

Device Description : The Insight Infrared Video Goggles are designed to be used by clinicians to visu The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.

Device Class : 2

Duns Number: 016038297

Premarket Exempt : No

Product Code : GWN

Prescription Use : Yes

Device Count : 1

Vestibular First - 00860002280738 Catalog Number : INSIGHT-VIDEO-GOGGLES-PRO

Device Description : The Insight Infrared Video Goggles Pro are intended for viewing and recording ey The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.