FDA device listing
Achillo Sensa,Active Contour Ankle Joint,Ankle Support,Carbon Ankle Seven,Concealed Spring Ankle Joint,Dual Function…
FDA device listing 1603995495 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | Achillo Sensa,Active Contour Ankle Joint,Ankle Support,Carbon Ankle Seven,Concealed Spring Ankle Joint,Dual Function Ankle Joint,Dyna Ankle - Dynamic Ankle Orthosis,FitKit WalkOn Flex Junior,FitKit WalkOn Lateral,FitKit WalkOn Lateral Junior,FitKit WalkOn Reaction Lateral,Foot stirrup,GoOn,Heel Relief Orthosis Des. By Dr. Settner,Heel wedges 10 degrees, 16 degrees, 22 degrees,Heel wedges 15… |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | OTTO BOCK (CHINA) INDUSTRIES CO., LTD., OTTO BOCK HEALTHCARE LP, Ottobock Manufacturing Bulgaria EOOD, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 1721652, 9611742, 9616494, 3018070833 |
| FEI numbers | 1721652, 3003117095, 3003117657, 3018070833 |
| Establishment operations | Contract Manufacturer, Manufacturer, Foreign Exporter, Specification Developer, Repackager/Relabeler |
| 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