OculoMotor Technologies
VERVE is software that provides virtual-reality vision exercises for convergence insufficiency. The system presents visual targets through a tablet and VR headset, while integrated eye…
Digital Therapy Device for Convergence Insufficiency
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Hunan.
- Changsha Airdoc Health Technology Co., Ltd. Hunan, contract manufacturer
What Is This Device?
A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
How Is SBN Classified?
Digital Therapy Device For Convergence Insufficiency is FDA product code SBN, Class 1, 21 CFR 886.1290.
How Does It Reach the US Market?
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.
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