FDA Device Establishments · JSON-LD · Markdown
FEI 3003117657 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3003117657 |
|---|---|
| Owner / Operator | Ottobock SE & Co. KGaA (#8010097) |
| Address | Max-Naeder-Strasse 15, DUDERSTADT Lower Saxony, D-37115, DE |
| Mandatory US Agent | Otto Bock HealthCare LP |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IOY |
| Regulation § (21 CFR) | 890.3475 |
| Proprietary names | UD Tennis Elbow Sleeve; QD Elbow Sleeve; X-RX Elbow Support; PRN Elbow Pad Jr; X-RX Wrist Support; UD X-Stable Shoulder Brace; PRN Original Elbow Pad Jr; PRN Elbow Pad; QD Forearm Sleeve 1,5mm Pair Black; RX Original Elbow Sleeve |
Source: openFDA. Public-domain (CC0).