FDA device listing
Kinetec,Kinetec 6080,Kinetec Breva,Kinetec Centura,Kinetec Centura B&W,Kinetec Centura Elbow Module,Kinetec Centura…
FDA device listing 1151271867 · Kinetec USA, Inc.
Key facts
| Proprietary names | Kinetec,Kinetec 6080,Kinetec Breva,Kinetec Centura,Kinetec Centura B&W,Kinetec Centura Elbow Module,Kinetec Centura Lite,Kinetec Kinevia,Kinetec Kompanion,Kinetec Maestra,Kinetec Performa,Kinetec Prima Advance,Kinetec Prima XL,Kinetec Spectra,Kinetec Spectra Essential,Kinetec Spectra XL,Kinetec USA,Kinevia AL |
|---|---|
| Owner/operator | Kinetec USA, Inc. |
| Owner/operator number | 10045573 |
| Product codes | BXB |
| Device names | BXB - Exerciser, Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5380 |
| Review panels | Physical Medicine |
| Registered establishments | Kinetec SAS, KINETEC USA |
| Establishment registrations | 8020836, 3010675856 |
| FEI numbers | 3006734242, 3010675856 |
| Establishment operations | Manufacturer, 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