Product code QWI

Device name

Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

Medical specialty

Neurology

Device class

2

Regulation number

882.5804

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms

Source

FDA openFDA device classification dataset