FDA device listing
Secure All Finger Control Mitt
FDA device listing 1370368452 · DJO, LLC
Key facts
| Proprietary names | Secure All Finger Control Mitt |
|---|---|
| Owner/operator | DJO, LLC |
| Owner/operator number | 9015378 |
| Premarket submissions | K963554 |
| Product codes | FMQ |
| Device names | FMQ - Restraint, Protective |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6760 |
| Review panels | General Hospital |
| Registered establishments | DJO, LLC, DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Establishment registrations | 9616086, 3017264244 |
| FEI numbers | 3006076154, 3017264244 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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