QVY · Class II · 21 CFR 880.5151

FDA Product Code QVY: Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome

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).

Leading manufacturers include Prapela, Inc..

1
Total
0
Cleared
291d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome Devices (Product Code QVY)

1 devices
1–1 of 1
Not Cleared Apr 04, 2025
Prapela SVS hospital bassinet pad (model P01)
DEN240031
Prapela, Inc.
General Hospital · 291d

About Product Code QVY - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QVY since 2025, with 0 receiving FDA clearance (average review time: 291 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

QVY devices are reviewed by the General Hospital panel. Browse all General Hospital devices →