FDA Device Establishments · JSON-LD · Markdown
FEI 3010386378 · Manufacture Medical Device · Status: Active
| FEI Number | 3010386378 |
|---|---|
| Owner / Operator | DX Products Limited (#10044627) |
| Address | Unit 1 Horbury Junction Industrial Estate, Calder Vale Rd, Horbury Wakefield, WF4 5ER, GB |
| Mandatory US Agent | Heyer Regulatory Solutions, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LKY |
| Regulation § (21 CFR) | 876.5020 |
| Proprietary names | Bathmate Hydromax X20, X20 Xtreme, X30, X30 Xtreme, X40, X40 Xtreme, X50 Xtreme (and accessories); Bathmate Hercules (and accessories); VaxAid V5 Deluxe, VaxAid V6 Deluxe,, VaxAid V7 Deluxe, VaxAid V8 Deluxe, VaxAid V9 Deluxe (and accessories); Xersizer 5, Xersizer Pro 6, Xersizer 7, Xersizer Pro 5, Xersizer Pro 7, Xersizer Pro 8, Xersizer Pro 9 (and accessories); Bathmate Hydromax3, Hydromax5, Hydromax6, Hydromax7, Hydromax7 Wide Boy, Hydromax 8, Hydromax9 (and accessories); Bathmate HydroXtreme3, HydroXtreme5, HydroXtreme7, HydroXtreme7 Wide Boy, HydroXtreme 8, HydroXtreme9, HydroXtreme11; Xersizer Pro 5X, Xersizer Pro 7X, Xersizer Pro 9X (and accessories); Bathmate Hydro7 (and accessories); HydroXtreme 6, HydroXtreme 8; Bathmate Spartan, Barbarian, Gladiator Power Rings, Maximus Power Rings |
Source: openFDA. Public-domain (CC0).