DEN240031 is an FDA 510(k) submission for the Prapela SVS hospital bassinet pad (model P01). This device is classified as a Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome (Class II - Special Controls, product code QVY).
Submitted by Prapela, Inc. (Biddeford, US). The FDA issued a Not Cleared (DENG) decision on April 4, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5151. 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)..
| 510(k) Number | DEN240031 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 17, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 291 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QVY - Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5151 |
| Definition | 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). |