FDA device listing
H-400 Bilateral Hip-Knee Torsion Shafts Attached to AFO's,K-400 Bilateral Hip-KAFO Torsion Splint,L-400 Bilateral…
FDA device listing 1126836609 · BECKER ORTHOPEDIC APPLIANCE CO.
Key facts
| Proprietary names | H-400 Bilateral Hip-Knee Torsion Shafts Attached to AFO's,K-400 Bilateral Hip-KAFO Torsion Splint,L-400 Bilateral Hip-Ankle Torsion Splint,R-400 Bilateral Hip-Knee-Ankle Torsion Splint,TORSION SPLINT |
|---|---|
| Owner/operator | BECKER ORTHOPEDIC APPLIANCE CO. |
| Owner/operator number | 1824252 |
| Product codes | ITO |
| Device names | ITO - Twister, Brace Setting |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3410 |
| Review panels | Physical Medicine |
| Registered establishments | BECKER ORTHOPEDIC APPLIANCE CO. |
| Establishment registrations | 1824252 |
| FEI numbers | 1000042994 |
| Establishment operations | 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