Skip to contentDe Novo DEN240031
- Device
- Prapela SVS hospital bassinet pad (model P01)
- Contact
- john konsin
- De Novo number
- DEN240031
- Product code
- QVY
- Regulation
- 880.5151
- Classification name
- therapeutic vibrational mattress pad, adjunct use in neonatal abstinence syndrome or neonatal opioid withdrawal syndrome
- Decision
- granted (DENG)
- Decision date
- 2025-04-04
- Date received
- 2024-06-17
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QVY
- Device name
- Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.5151
- Implant
- N
- Life sustain/support
- N