FDA device listing
Cybertech Chairback Frame,Cybertech Premium Plus,DONJOY Lite,DONJOY Low Profile,EXOS FORM II,LSO Low…
FDA device listing 1555223599 · DJO, LLC
Key facts
| Proprietary names | Cybertech Chairback Frame,Cybertech Premium Plus,DONJOY Lite,DONJOY Low Profile,EXOS FORM II,LSO Low Profile,SACRO-LUMBAR SUPPORTS,Standard Chairback |
|---|---|
| Owner/operator | DJO, LLC |
| Owner/operator number | 9015378 |
| Product codes | IQE |
| Device names | IQE - Orthosis, Lumbar |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | DJO FRANCE SAS, DJO, LLC, DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V., DJO Tunisia, DJO Tunisie |
| Establishment registrations | 9616086, 3007502541, 3007615436, 3011120089, 3017264244 |
| FEI numbers | 3006076154, 3007502541, 3007615436, 3011120089, 3017264244 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| 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