FDA Device Establishments · JSON-LD · Markdown
FEI 3011014178 · Manufacture Medical Device · Status: Active
| FEI Number | 3011014178 |
|---|---|
| Owner / Operator | Kessel medintim GmbH (#10048803) |
| Address | Kelsterbacher Str. 28, Morfelden-Walldorf Hesse, 64546, DE |
| Mandatory US Agent | HPSRX ENTERPRISES, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LKY |
| Regulation § (21 CFR) | 876.5020 |
| Proprietary names | Rehabi Penile Vacuum Trainer; Manual Erection System; Active3 Erection System; Constriction ring 21mm; Constriction ring 9mm; Constriction ring 15mm; Constriction ring 12 mm; Constriction ring 18mm |
Source: openFDA. Public-domain (CC0).