Self Vision Tester

When users put their forehead to the forehead sensor, VAA-2000PCE starts the examination automatically. To see the indications (pictures, numbers, Korean Alphabet, Landolt rings and etc.)…

Registry build 21.09.26

When users put their forehead to the forehead sensor, VAA-2000PCE starts the examination automatically. To see the indications (pictures, numbers, Korean Alphabet, Landolt rings and etc.) through the tester’s eyepiece, users keep eyes on the indication in the middle of background and the indications on every sides. Then move the lever to the same indication to the indication in the middle. If users cannot distinguish the indications, push on of the red buttons on the left and right sides to forgive. Then it skips the phase and change to next indication. When the exam finished, the device analyzes user’s choices and give the result data of the exam. Users can check their eyesight data by printing it from device. In addition, the device prevents user’s mistake by voice guidance To start the color-blindness test, touch the 10.1-inch LCD touch-screen at the top of the device. The indications on the center of the screen are displayed on the LCD touch screen. Touch the displayed indication by one-step multiple-choice color vision test, and then the same type of color vision test will be performed in several steps. Users touch the LCD screen to proceed with the test, the test will be completed. After the test is completed, you can print out the results of the color test on the print paper by touching the print button on the touch screen.

21manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (5), Chongqing (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HOX
Manufacturer City Province Registered as Device types
DU-Hope International Group Nanjing Jiangsu Contract manufacturer 11
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
Beijing Hongdee Corporation Beijing Beijing Private-label distributor 43
Danyang NEW Hope Medical Equipment Co., Ltd. Danyang Jiangsu Manufacturer 38
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
Wuxi Zontai Int’l Corporation Ltd. Wuxi Jiangsu Contract manufacturer 22
Shanghai Link Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 21
Gino Optical (Shanghai) Co., Ltd. Shanghai Shanghai Manufacturer 15
Shanghai Mediworks Precision Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 13
MDF Instruments Medifriend Inc. Song Jiang District Shanghai Repacker / relabeller 13
Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. Nanjing Jiangsu Contract manufacturer 12

Showing 12 of 21. All 21 manufacturers in China registered for Chart, Visual Acuity

Record

Regulatory record for Self Vision Tester
Listed by View-M Technology Co., Ltd., South Korea
FDA product code HOX
Device type Chart, Visual Acuity
Device class Class 1
Regulation 21 CFR 886.1150
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-03-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Storage Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 55 °C

Catalogue Numbers

Catalogue numbers for Self Vision Tester
Catalogue number Size Status
VAA-2000PCE In distribution
VAA-2000PSE In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Visual Chart System View-M Technology Co., Ltd. 9
VT1 FIM Medical 8
Visionix Luneau Technology Operations 5
AMA Optics Eye Chart AMA Optics, Inc. 5
Lambda 100 Heine Optotechnik Gmbh & Co. KG. 4
AMA Optics Retinometer AMA Optics, Inc. 4
Yeasn Chongqing Yeasn Science-Technology Co., Ltd. 3
Optego Optego Vision USA, Inc. 3
Topcon Visia Imaging SRL 3
Chart Projector Nidek Incorporated 2
NearBright Reichert Inc. 2
Mirror Chart MC-5S for Compu Vision CV-5000 Topcon Corp. 2

Showing 12 of 60. All products under Chart, Visual Acuity

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer