FDA device listing
Hand night splint for 28P30,Manu Immobil Long Wristorthosis,Manu Neurexa, Plus,Wrist Splint Manu Immobil
FDA device listing 1093415796 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | Hand night splint for 28P30,Manu Immobil Long Wristorthosis,Manu Neurexa, Plus,Wrist Splint Manu Immobil |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | ILH |
| Device names | ILH - Splint, Hand, And Components |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | Ottobock Manufacturing Bulgaria EOOD, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 9616494, 3018070833 |
| FEI numbers | 3003117657, 3018070833 |
| Establishment operations | Contract Manufacturer, 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