QVY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5151
- Medical specialty
- General Hospital
- FDA 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).
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Prapela SVS hospital bassinet pad (model P01) (DEN240031) | Prapela, Inc. | 2025-04-04 |
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