Data / Medical devices / Fixation, Vision Training, Binocular
Fixation, Vision Training, Binocular (NXR): 13 FDA-registered makers in 7 countries
13 establishments in 7 countries are registered with the FDA to make Fixation, Vision Training, Binocular (product code NXR, Class 1, 21 CFR 886.1290). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 17, 2006, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NXR
- Device class
- 1
- Regulation
- 886.1290
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 3 |
| Spain | 1 |
| South Korea | 1 |
| India | 1 |
| Israel | 1 |
| Turkey | 1 |
Makers of Fixation, Vision Training, Binocular
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beijing Mingren Shikang Technology Co., Ltd. | Beijing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E-Health Technical Solutions S.L. | Barcelona, Spain | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edenlux Corp. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresnel Prism & Lens Co. | Bloomington, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulden Ophthalmics | Elkins Park, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HTS, Inc. | Gold Canyon, AZ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novasight | Airport City Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novavision, Inc. | Boca Raton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculera Saglik Teknolojileri A.S. | Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivid Vision | San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Zontai Int'l Corporation Ltd. | WUXI Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 17, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.