510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240031Unknown

Prapela SVS hospital bassinet pad (model P01)

Prapela, Inc., Biddeford ME / Direct, Unknown
FDA source (opens on fda.gov)

DEN240031 is the FDA 510(k) clearance record for Prapela SVS hospital bassinet pad (model P01), a class II device, cleared for Prapela, Inc. on under FDA product code QVY (Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome). FDA's definition for product code QVY reads: "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)". FDA records list one 510(k) clearance for Prapela, Inc. As of , FDA records show no recalls naming DEN240031.

Clearance record

Decision date
Received
(291 days to decision)
Product code
QVY Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
Regulation
21 CFR 880.5151
Device class
Class II
Review panel
General Hospital
Applicant
Prapela, Inc. 2 Main St. Suite 15-219, Biddeford ME
Third party review
No

Clearances, product code QVY

Trailing 12 months

FDA records hold no clearances under product code QVY in the trailing twelve months.

FDA records show no clearances under product code QVY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260