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Verity Medical Ltd (Ireland): FDA-registered device maker in Tagoat Wexford, Ireland, 6 510(k) clearances

Name: Verity Medical Ltd (Ireland) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Verity Medical Ltd (Ireland) is registered with the FDA (registration 3019822804) in Tagoat Wexford, Ireland. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 26, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3019822804
Address: Churchtown House, Tagoat Wexford, Ireland, Y35 XY44
Owner or operator: Verity Medical Ltd (10023123)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: July 21, 2009
Registered through: 2027
Brand names listed: Mantra Electrode, Mantra TENS Model NT3, Medline DeNovo 4Pro Electrical Stimulation Device, NGXNUHGSM HD Combo (OTC), Neuro20 PRO, NeuroTrac® MyoPlus Pro, Xiniwave

Devices it lists

Device	Product code	Class	Role	Source
Device, Biofeedback	HCC	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Contract manufacturer	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
June 26, 2025	K243079	NeuroTrac® MyoPlus Pro (MYO120U)	KPI	Substantially Equivalent	Verity Medical , Ltd.	accessdata.fda.gov
July 15, 2010	K100441	XINIWAVE, MODEL XW-18	NUH	Substantially Equivalent	International Trade Group, Inc.	accessdata.fda.gov
July 30, 2009	K091236	MANTRA COMBO, MODEL MECS 320	GZJ	Substantially Equivalent	Mantra Intl. (Hk) , Ltd.	accessdata.fda.gov
July 14, 2009	K083704	NUTRAC PELVATOR, MODEL PEL 200	KPI	Substantially Equivalent	Verity Scientific , Ltd.	accessdata.fda.gov
September 22, 2004	K041902	MANTRA ELECTRODE	GXY	Substantially Equivalent	Mantra Intl. (Hk) , Ltd.	accessdata.fda.gov
September 3, 2004	K041520	MANTRA TENS MODEL NT3	GZJ	Substantially Equivalent	Mantra Intl. (Hk) , Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 26, 2025. 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.