QVYClass II
Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
21 CFR 880.5151 / General Hospital
QVY is the FDA product code for Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome, a class II device type, regulated under 21 CFR 880.5151. FDA's definition for this code 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)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QVY
- Device name
- Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
- FDA 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).
- Regulation
- 21 CFR 880.5151
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QVY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code QVY| Applicant | Clearances |
|---|---|
| Prapela, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.