FDA device listing
AeroLink Hybrid Liner,AK Adapt Liner,AK Prosthetic Shrinker,AxonSkin Silicone Glove,bebionic Silicone Glove,Bebionic…
FDA device listing 1001344306 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | AeroLink Hybrid Liner,AK Adapt Liner,AK Prosthetic Shrinker,AxonSkin Silicone Glove,bebionic Silicone Glove,Bebionic skin silicone,Bebionic skin silicone black,BK Prosthetic Shrinker,Caleo,Caleo 3D,C-Leg Guard,C-Leg Protective Cover w/o shield,C-Leg Protector,Compression Liner Cushion,Compression Liner Locking,Compression Shrinker for transfem.amp.CCL1,Compression Shrinker for… |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | IPM |
| Device names | IPM - Cover, Limb |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | OTTO BOCK HEALTHCARE CANADA, OTTO BOCK HEALTHCARE LP, Otto Bock Healthcare Products GmbH, Ottobock Manufacturing Bulgaria EOOD, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 1721652, 9616494, 1000228440, 3005190268, 3018070833 |
| FEI numbers | 1721652, 1000228440, 3003117657, 3005190268, 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