510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QVOClass II

Computerized Behavioral Therapy Device For Insomnia

21 CFR 882.5801 / Neurology
FDA source (opens on fda.gov)

QVO is the FDA product code for Computerized Behavioral Therapy Device For Insomnia, a class II device type, regulated under 21 CFR 882.5801. FDA's definition for this code reads: "The device is intended to provide cognitive behavioral therapy to treat insomnia". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QVO
Device name
Computerized Behavioral Therapy Device For Insomnia
FDA definition
The device is intended to provide cognitive behavioral therapy to treat insomnia.
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QVO

By decision year
2 clearances under product code QVO with a decision year between 2020 and 2024, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVO by decision year
YearClearances
20201
20241

Applicants with the most clearances

Product code QVO
Applicants holding the most 510(k) clearances under product code QVO
ApplicantClearances
Big Health Inc1
Pear Therapeutics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code