QVY · Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
General Hospital · 21 CFR 880.5151 · Class 2
Overview
| Product Code | QVY |
|---|---|
| Device Name | Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome |
| Regulation | 21 CFR 880.5151 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
The Prapela SVS hospital bassinet pad (model P01) is a non-sterile, reusable, hospital mattress pad with an embedded transducer that produces small-input stochastic stimulations (vibrations) that resonate through the foam. It is indicated as adjunctive non-pharmacological therapy in newborns ≥37 weeks gestational age exposed prenatally to opioids with neonatal opioid withdrawal syndrome (NOWS).
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, with risks mitigated by general and special controls.
Special Controls
In combination with the general controls of the FD&C Act, the therapeutic vibrational mattress pad is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240031 | Prapela SVS hospital bassinet pad (model P01) | Prapela, Inc. | Apr 4, 2025 | DENG |
Top Applicants
- Prapela, Inc. — 1 clearance
