FDA device listing
Breathwell,Gumchucks,O2 nasal dilator,Oralwise,Protego nasal dilator,Sleepwell
FDA device listing 1746825020 · NINGHAI LUOJIA ELECTRONICS CO.,LTD
Key facts
| Proprietary names | Breathwell,Gumchucks,O2 nasal dilator,Oralwise,Protego nasal dilator,Sleepwell |
|---|---|
| Owner/operator | NINGHAI LUOJIA ELECTRONICS CO.,LTD |
| Owner/operator number | 10040451 |
| Product codes | LWF |
| Device names | LWF - Dilator, Nasal |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.3900 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | NINGHAI LUOJIA ELECTRONICS SC., LTD |
| Establishment registrations | 3009566748 |
| FEI numbers | 3009566748 |
| 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