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

QVY is the FDA product code for therapeutic vibrational mattress pad, adjunct use in neonatal abstinence syndrome or neonatal opioid withdrawal syndrome. It is a Class II device, regulated under 21 CFR 880.5151 and reviewed by the General Hospital panel. Devices under QVY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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).

Classification

Recalls for QVY devices

openFDA lists no recalls for product code QVY.

Frequently asked questions

What is FDA product code QVY?

QVY is the FDA product code for therapeutic vibrational mattress pad, adjunct use in neonatal abstinence syndrome or neonatal opioid withdrawal syndrome. It is a Class II device, regulated under 21 CFR 880.5151 and reviewed by the General Hospital panel.

What device class is QVY?

Class II, regulation 21 CFR 880.5151. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QVY
• Run a recall and safety report across every QVY manufacturer
• Watch product code QVY for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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