FDA device listing
AeroWalker, pneumatic transtibial-foot-orthosis,AeroWalker.short, pneumatic transtibial-foot-orthosis,Dorsal Night…
FDA device listing 1463220663 · Streifeneder ortho.production GmbH
Key facts
| Proprietary names | AeroWalker, pneumatic transtibial-foot-orthosis,AeroWalker.short, pneumatic transtibial-foot-orthosis,Dorsal Night Stabilisation Splint,Foot Postural Support Orthosis,GenuMax,Knee Joint Support with silicone pads,PediSupport.dorsal |
|---|---|
| Owner/operator | Streifeneder ortho.production GmbH |
| Owner/operator number | 8010401 |
| Product codes | IQI |
| Device names | IQI - Orthosis, Limb Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | STREIFENEDER ortho.production gmbH |
| Establishment registrations | 8010401 |
| FEI numbers | 5812 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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