510(k) K233577
K233577 is an FDA 510(k) premarket notification submitted by Big Health, Inc. for the device "Sleepio®". The FDA issued a decision of Substantially Equivalent on Aug 5, 2024. The device falls under product code QVO (Computerized Behavioral Therapy Device For Insomnia), a Class II device regulated under 21 CFR 882.5801. Big Health, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2024
- Date Received
- Nov 7, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Computerized Behavioral Therapy Device For Insomnia
- Device Class
- Class II
- Regulation Number
- 882.5801
- Review Panel
- NE
- Submission Type
- 510(k)
The device is intended to provide cognitive behavioral therapy to treat insomnia.