FDA device listing
Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads,Ascend Cervical Collar,Ascend…
FDA device listing 1799816946 · Breg Inc
Key facts
| Proprietary names | Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads,Ascend Cervical Collar,Ascend Pediatric Collar,Carlsbad Cervical Collar,Cervical Collar,Cervical Traction Kit,Pinnacle 172/174/180,Pinnacle CTO,Pinnacle CTO4 |
|---|---|
| Owner/operator | Breg Inc |
| Owner/operator number | 10041297 |
| Product codes | IQK |
| Device names | IQK - Orthosis, Cervical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | BREG, INC., BREG, INC.,, BREG MEXICO, S. DE R.L. DE C.V. (3), BREG MEXICO, S. DE R.L. DE C.V. (4) |
| Establishment registrations | 2028253, 3010694026, 3015960622, 3027500264 |
| FEI numbers | 1000125378, 3010694026, 3015960622, 3027500264 |
| 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