Otus® Fixation, Vision Training, Binocular
Vision Training Device, Battery-powered
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Mingren Shikang Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Edenlux Corp., South Korea |
|---|---|
| FDA product code | NXR |
| Device type | Fixation, Vision Training, Binocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1290 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LRS2-400FB1-M0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fresnel Prism AND Lens | Fresnel Prism & Lens Co. | 2 |
| Brock String | Gulden Ophthalmics | 1 |
| NeuroEyeCoach | Novavision, Inc. | 1 |
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.