QVO — Computerized Behavioral Therapy Device For Insomnia Class II

FDA Device Classification

Classification Details

Product Code
QVO
Device Class
Class II
Regulation Number
882.5801
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233577big healthSleepio®August 5, 2024
K191716pear therapeuticsSomrystMarch 23, 2020