DeviceClearance

Product code QWI— Neurology

Stanza

Classification name
Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
Device class
Class 2
Regulation
21 CFR 882.5804
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QWI under 21 CFR 882.5804, via openFDA

Market context for product code QWI

FDA has cleared 1 device under product code QWI, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QWI

Recent clearances under product code QWI

Data sourced from openFDA. This site is unofficial and independent of the FDA.