QVO

Computerized Behavioral Therapy Device For Insomnia

Product code
QVO
Device name
Computerized Behavioral Therapy Device For Insomnia
Device class
Class 2
21 CFR
21 CFR 882.5801
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-05.

NumberDecision dateApplicantDevice nameSummary
K2335772024-08-05Big Health, Inc.Sleepio®FDA
Official FDA classification page: QVO
Classification and pathway per current FDA publications. Data from openFDA (CC0).