Data / Medical devices / United Kingdom / DX Products Limited

DX Products Limited: FDA-registered device maker in Horbury Wakefield, United Kingdom, 1 510(k) clearance

Name: DX Products Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DX Products Limited is registered with the FDA (registration 3010386378) in Horbury Wakefield, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 27, 2016. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010386378
Address: Unit 1 Horbury Junction Industrial Estate Calder Vale Rd, Horbury Wakefield, United Kingdom, WF4 5ER
Owner or operator: DX Products Limited (10044627)
Roles: Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: July 5, 2013
Registered through: 2027
Brand names listed: Bathmate Hercules (and accessories), Bathmate Hydro7 (and accessories), Bathmate HydroXtreme3, HydroXtreme5, HydroXtreme7, HydroXtreme7 Wide Boy, HydroXtreme 8, HydroXtreme9, HydroXtreme11, Bathmate Hydromax X20, X20 Xtreme, X30, X30 Xtreme, X40, X40 Xtreme, X50 Xtreme (and accessories), Bathmate Hydromax3, Hydromax5, Hydromax6, Hydromax7, Hydromax7 Wide Boy, Hydromax 8, Hydromax9 (and accessories), Bathmate Pleasure Lube, Bathmate Spartan, Barbarian, Gladiator Power Rings, Maximus Power Rings, HydroXtreme 6, HydroXtreme 8 and more

Devices it lists

Device	Product code	Class	Role	Source
Device, External Penile Rigidity	LKY	2	Manufacturer	accessdata.fda.gov
Lubricant, Personal	NUC	2	Exporter to the US, Foreign private label distributor	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 27, 2016	K160211	Wet Original Personal Lubricant	NUC	Substantially Equivalent	Trigg Laboratories D/B/A Wet International	accessdata.fda.gov

Compare with other makers

Updated April 27, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.