FDA.reportPublic FDA data

Vestibular First

Primary DI
00860002280745
Brand
Vestibular First
Company
Vestibular First, LLC
Model
Insight Infrared Video Goggles Pro+
Catalog number
INSIGHT-PRO-PLUS
Device description
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.
Published
2023-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203082000Insight Infrared Video GogglesVestibular First2020-11-12GWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860002280742PackageGS16In Commercial Distribution
00860002280745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000228074210860002280742
00860002280745008600022807458600022807450860002280745

GMDN Terms#

Term, Definition table
TermDefinition
Eye/eyelid movement monitoring spectacles/gogglesAn electrically-powered optical device intended to monitor eyelid and/or eye movements to assist in the detection of alertness/drowsiness, epileptic seizures, and/or to assist in the identification of vestibular disorders. It consists of a spectacle/goggle-like frame and may include an infrared sensor(s), infrared LED(s), infrared video camera(s), and/or a photodiode(s); it transmits a digital signal to a processing unit, which may use an off-the-shelf video viewing software application.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
215-667-8990support@vestibularfirst.com

Regulatory Flags#

DUNS number
016038297
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002280738Vestibular FirstInsight Infrared Video Goggles ProINSIGHT-VIDEO-GOGGLES-PRO2021-11-11
00860002280714Vestibular FirstInsight Disposable Cushions - 40-CountPART-DISPOSABLE-CUSHION-40CT2023-06-01
10860002280742Vestibular FirstInsight Infrared Video Goggles Pro+INSIGHT-PRO-PLUS2023-06-01
10860002280735Vestibular FirstInsight Infrared Video Goggles ProINSIGHT-VIDEO-GOGGLES-PRO2021-11-11
00860002280707Vestibular FirstInsight Infrared Video Goggles2020-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B516327270Instrumentation Difra SAInstrumentation Difra SAGWN2026-03-09
05711117244991InteracousticsInteracoustics A/SGWN2025-08-14
05711117245004InteracousticsInteracoustics A/SGWN2025-08-14
05711117245028InteracousticsInteracoustics A/SGWN2025-08-14
00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
B516325950Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326290Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326380Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
057133150107361091, ICS Dizcovery SystemNatus Medical Denmark ApSGWN2025-02-21
057133150108111091, ICS Dizcovery ShadeShift Panels Natus Medical Denmark ApSGWN2025-02-21
057133150108281091, ICS Dizcovery LCD PanelsNatus Medical Denmark ApSGWN2025-02-21
057133150108801091, ICS Dizcovery Universal Face Cushion (qty 40)Natus Medical Denmark ApSGWN2025-02-21
08054187380815Synapsys VHITINVENTIS SRLGWN2025-01-08
08054187380822Synapsys VHITINVENTIS SRLGWN2025-01-08
B366VN1061R00VNG 3DEclerisGWN2024-12-17
05713315007132GN Otometrics A/SNatus Medical Denmark ApSGWN2024-12-04
08054187380983VNGINVENTIS SRLGWN2024-10-01
08054187380990VNGINVENTIS SRLGWN2024-10-01
08054187381003VNGINVENTIS SRLGWN2024-10-01
08054187381010VNGINVENTIS SRLGWN2024-10-01
08054187381027VNGINVENTIS SRLGWN2024-10-01
08054187381034VNGINVENTIS SRLGWN2024-10-01
08054187381041VNGINVENTIS SRLGWN2024-10-01
08054187381058VNGINVENTIS SRLGWN2024-10-01
08054187381065VNGINVENTIS SRLGWN2024-10-01
B516308640Instrumentation Difra SAInstrumentation Difra SAGWN2024-08-19
B366VN1061VNG 3DEclerisGWN2024-05-20
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
00763000467340NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWN2024-02-26