vestibularfirst.comInsight Infrared Video Goggles
Vestibular First
VESTIBULAR FIRST
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017632068 | 3017632068 | VESTIBULAR FIRST | 1 | N | 2026-01-01 | 9 Mather Ave Broomall PA US 19008 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860002280707 | Vestibular First - 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. | 2156678990 | support@vestibularfirst.com |
| 00860002280714 | Vestibular First - The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions. | 215-667-8990 | support@vestibularfirst.com |
| 00860002280738 | Vestibular First - 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. | 215-667-8990 | support@vestibularfirst.com |
| 00860002280745 | Vestibular First - 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. | 215-667-8990 | support@vestibularfirst.com |
| 10860002280735 | Vestibular First - 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. | 215-667-8990 | support@vestibularfirst.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 282943 | 1619603098 | K203082 | Insight Infrared Video Goggles | GWN | 2020-11-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GWN | 1 | 2020-11-12 |
PMN#
GUDID#
Vestibular First - 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.
2021-11-11
Vestibular First - 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.
2023-06-01
Vestibular First - The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions.
2023-06-01
Vestibular First - 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.
2023-06-01
Vestibular First - 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.
2021-11-11
Vestibular First - 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.
2020-11-17