QVO · Class II · 21 CFR 882.5801

FDA Product Code QVO: Computerized Behavioral Therapy Device For Insomnia

The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Insomnia.

Leading manufacturers include Pear Therapeutics, Inc. and Big Health, Inc..

2
Total
2
Cleared
272d
Avg days
2020
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Computerized Behavioral Therapy Device For Insomnia Devices (Product Code QVO)

2 devices
1–2 of 2
Cleared Aug 05, 2024
Sleepio®
K233577
Big Health, Inc.
Neurology · 272d
Cleared Mar 23, 2020
Somryst
K191716
Pear Therapeutics, Inc.
Neurology · 271d

About Product Code QVO - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QVO since 2020, with 2 receiving FDA clearance (average review time: 272 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.