FDA device listing
Prapela SVS hospital bassinet pad
FDA device listing 2013467502 · Saunders Electronics
Key facts
| Proprietary names | Prapela SVS hospital bassinet pad |
|---|---|
| Owner/operator | Saunders Electronics |
| Owner/operator number | 10055706 |
| Product codes | QVY |
| Device names | QVY - Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5151 |
| Review panels | General Hospital |
| Registered establishments | SAUNDERS ELECTRONICS |
| Establishment registrations | 3013919529 |
| FEI numbers | 3013919529 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database