Who else makes this device?

Name: RightEye Vision System
Brand: RightEye Vision System

RightEye Vision System

RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and…

Registry build 21.09.26

RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and reports eye movements in real-time.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Beijing (1).

Chinese manufacturers registered for FDA product code GWN
Manufacturer	City	Province	Registered as	Device types
Isen Tech.&Trading Co., Ltd.	Beijing	Beijing	Manufacturer	2
E-Business International Inc.	Shenzhen	Guangdong	Exporter	2
Huizhou Maxway Technology Co., Ltd.	Huizhou	Guangdong	Contract manufacturer	2

Record

Regulatory record for RightEye Vision System
Listed by	Righteye, LLC, United States
FDA product code	GWN
Device type	Nystagmograph
Device class	Class 2
Regulation	21 CFR 882.1460
Premarket notification	Exempt
Record published	2023-03-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for RightEye Vision System
Catalogue number	Size	Status
Tobii Dynavox i15		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GN Otometrics A/S	Natus Medical Denmark ApS	17
Interacoustics	Interacoustics A/S	15
VNG	Inventis SRL	9
Instrumentation Difra SA	Instrumentation Difra SA	8
Nystagmograph	Medtronic PS Medical	7
Instrumentation Difra	Instrumentation Difra SA	7
Otometrics	Natus Medical Denmark ApS	5
Vestibular First	Vestibular First	4
Micromedical Technologies	Micromedical Technologies, Inc.	3
Complete Monocular wireless Smart Cam system with Xpress mask	Synapsys SA	2
Synapsys Vhit	Inventis SRL	2
EYE-Sync	Neurosync, Inc.	2

Showing 12 of 37. All products under Nystagmograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181771	2018-09-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.