FDA device listing
ARTHROFIX,CALCALASTIC,CALCALASTIC LONG,ELASTIC THUMB SUPPORT,NEURO-LUX II,OMO-HiT,OMO-LUX,RHIZO-HiT,RHIZO-HiT…
FDA device listing 1320400630 · SPORLASTIC GMBH
Key facts
| Proprietary names | ARTHROFIX,CALCALASTIC,CALCALASTIC LONG,ELASTIC THUMB SUPPORT,NEURO-LUX II,OMO-HiT,OMO-LUX,RHIZO-HiT,RHIZO-HiT CLASSIC,RHIZO-RING,RHIZO-RING SOFT,RHIZOSPLINT,STUTTGART SHOULDER-ARM SUPPORT,SWEDE-O-UNIVERSAL,SWEDE-O-UNIVERSAL X8,THUMB SADDLE JOINT BRACE |
|---|---|
| Owner/operator | SPORLASTIC GMBH |
| Owner/operator number | 9033265 |
| 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 | SPORLASTIC GMBH & Co.KG |
| Establishment registrations | 3005083016 |
| FEI numbers | 3005083016 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler, 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