Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010386378

FEI Number

3010386378

Entity Name

DX PRODUCTS LIMITED

City/State/Country

Horbury Wakefield, GB

Establishment Address

Unit 1 Horbury Junction Industrial Estate, Calder Vale Rd, Horbury Wakefield WF4 5ER, GB

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DX Products Limited (Owner Number: 10044627)

Owner / Operator Contact Address

Unit 1 Horbury Junction Industrial Estat, Calder Vale Rd, Horbury, GB-WKF WF4 5ER, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160211

PMA Number

N/A

All Registered 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 HydroXtreme3, HydroXtreme5, HydroXtreme7, HydroXtreme7 Wide Boy, HydroXtreme 8, HydroXtreme9, HydroXtreme11 Bathmate Hydro7 (and accessories) Xersizer Pro 5X, Xersizer Pro 7X, Xersizer Pro 9X (and accessories) Bathmate Hydromax3, Hydromax5, Hydromax6, Hydromax7, Hydromax7 Wide Boy, Hydromax 8, Hydromax9 (and accessories) HydroXtreme 6, HydroXtreme 8 Bathmate Spartan, Barbarian, Gladiator Power Rings, Maximus Power Rings VaxAid V7 Trainer and VaxAid V30 Bathmate Pleasure Lube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2013-07-05
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2020-02-27

Official Correspondent

Joe Mosalski

US Agent Details

Sheila Hemeon-Heyer Business: Heyer Regulatory Solutions, LLC Email: sheila@heyer-regulatory.com Phone: (413) 3308578

Related Public Records

Same Entity

DX Products Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010386378. Last updated year: 2026. Please use registration number 3010386378 when referencing this establishment in official correspondence.