FDA device listing
Various models
FDA device listing 1384513315 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | Various models |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | KNN |
| Device names | KNN - Components, Wheelchair |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3920 |
| Review panels | Physical Medicine |
| Registered establishments | OTTO BOCK (CHINA) INDUSTRIES CO., LTD., Ottobock Manufacturing Bulgaria EOOD, Otto Bock Manufacturing Konigsee GmbH, Otto Bock Mobility Solutions GmbH |
| Establishment registrations | 9611742, 9681725, 3007923118, 3018070833 |
| FEI numbers | 1000413464, 3003117095, 3007923118, 3018070833 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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