21 CFR 880.5151 — Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5151
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVY | Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome | 2 | 1 |
Special Controls
QVY — Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
In combination with the general controls of the FD&C Act, the therapeutic vibrational mattress pad is subject to the following special controls:
De Novo Order DEN240031
