510(k) DEN240031

Prapela SVS hospital bassinet pad (model P01) by Prapela, Inc. — Product Code QVY

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 4, 2025
Date Received: June 17, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
Device Class: Class II
Regulation Number: 880.5151
Review Panel: HO
Submission Type

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).