Product code QVO

Device name

Computerized Behavioral Therapy Device For Insomnia

Medical specialty

Neurology

Device class

2

Regulation number

882.5801

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The device is intended to provide cognitive behavioral therapy to treat insomnia.

Source

FDA openFDA device classification dataset