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.
Aid, Vision, Electronic, Battery-Powered
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.
- Zoomax Technology Co., Limited Zhejiang, contract manufacturer
How Is HPG Classified?
Aid, Vision, Electronic, Battery-Powered is FDA product code HPG, Class 1, 21 CFR 886.5900.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
Name
Record