FDA device listing
Modified Silesian Bandage,Plastic Suspension Strap
FDA device listing 1710789121 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | Modified Silesian Bandage,Plastic Suspension Strap |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | ISR |
| Device names | ISR - Band Or Belt, Pelvic Support |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 9616494 |
| FEI numbers | 3003117657 |
| Establishment operations | 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