Product Code: QVY
FDA class 2
21 CFR 880.5151
Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
General Hospital
510(k)s
1
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- QVY
- Device Class
- FDA class 2
- Regulation Number
- 880.5151
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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).
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240031 | Prapela SVS hospital bassinet pad (model P01) | Apr 04, 2025 | Unknown | Prapela, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.