DeviceClearance

Product code QVY— General Hospital

Prapela SVS hospital bassinet pad (model P01)

Classification name
Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
Device class
Class 2
Regulation
21 CFR 880.5151
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code QVY under 21 CFR 880.5151, via openFDA

Market context for product code QVY

FDA has cleared 1 device under product code QVY, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QVY

Recent clearances under product code QVY

Data sourced from openFDA. This site is unofficial and independent of the FDA.