FDA device listing
Spex for Bingo Lateral Trunk Support,Spex Head Support Pad,SPEX Lateral trunk supports
FDA device listing 1293038290 · LJ Solutions Inc
Key facts
| Proprietary names | Spex for Bingo Lateral Trunk Support,Spex Head Support Pad,SPEX Lateral trunk supports |
|---|---|
| Owner/operator | LJ Solutions Inc |
| Owner/operator number | 10096084 |
| Product codes | IMS |
| Device names | IMS - Support, Head And Trunk, Wheelchair |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3910 |
| Review panels | Physical Medicine |
| Registered establishments | MZ Vietnam Co.,LTD |
| Establishment registrations | 3041391447 |
| FEI numbers | 3041391447 |
| 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