FDA Device Establishments · JSON-LD · Markdown
FEI 3001917653 · Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3001917653 |
|---|---|
| Owner / Operator | Ottobock SE & Co. KGaA (#8010097) |
| Address | VIA FILIPPO TURATI 5/7, BUDRIO Bologna, 40054, IT |
| Mandatory US Agent | Otto Bock HealthCare LP |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IQE |
| Regulation § (21 CFR) | 890.3490 |
| Proprietary names | Lumbo Direxa High; Dorso Osteo Care Spinal Orthosis; Lumbo Direxa Stable; Spine Sport; Lumbo Sensa; Dorso Direxa Posture; Dorso Carezza Posture; Hyperextension brace; Lumbo Carezza; Dyneva light |
Source: openFDA. Public-domain (CC0).