510(k) DEN240031
DEN240031 is an FDA 510(k) premarket notification submitted by Prapela, Inc. for the device "Prapela SVS hospital bassinet pad (model P01)". The FDA issued a decision of De Novo Granted on April 4, 2025. The device falls under product code QVY (Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome), a Class II device regulated under 21 CFR 880.5151.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 4, 2025
- Date Received
- June 17, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
- Device Class
- Class II
- Regulation Number
- 880.5151
- Review Panel
- HO
- Submission Type
Reusable hospital mattress pad with integrated mechanical vibrations to be used as adjunctive therapy for neonates and infants with neonatal abstinence syndrome (NAS) or neonatal opioid withdrawal syndrome (NOWS).