FDA device listing
3 in 1 Step Down LSO,456 TLSO,456 TLSO Pro,464 TLSO Pro,621 SI Belt,625 Back Brace,626 LSO Essential,626 LSO Pro,626 LSO…
FDA device listing 1060286922 · VIVE Health LLC
Key facts
| Proprietary names | 3 in 1 Step Down LSO,456 TLSO,456 TLSO Pro,464 TLSO Pro,621 SI Belt,625 Back Brace,626 LSO Essential,626 LSO Pro,626 LSO Ultra,627 LSO Essential,627 LSO Pro,627 LSO Ultra,631 LSO Essential,631 LSO Pro,631 LSO Ultra,637 LSO Essential,637 LSO Pro,637 LSO Ultra,639 LSO Pro,639 LSO Ultra,Back Brace,Cross Support Back Brace,Hernia Belt,Industrial Bace Brace,Posture Corrector,SI Belt |
|---|---|
| Owner/operator | VIVE Health LLC |
| Owner/operator number | 10047487 |
| Product codes | IQE |
| Device names | IQE - Orthosis, Lumbar |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | VIVE Health LLC |
| Establishment registrations | 3011191255 |
| FEI numbers | 3011191255 |
| Establishment operations | Repackager/Relabeler |
| 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