Ocutech
Battery-operated ultrasonic sensor attached to eyeglasses that warns the wearer of an obstacle they may collide with in the non-seeing visual field.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zoomax Technology Co., Limited | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Ocutech, Inc., United States |
|---|---|
| FDA product code | HPG |
| Device type | Aid, Vision, Electronic, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SideSight | In distribution |
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.