Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019822804

FEI Number

3019822804

Entity Name

Verity Medical Ltd (Ireland)

City/State/Country

Tagoat Wexford, IE

Establishment Address

Churchtown House, Tagoat Wexford Y35 XY44, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Verity Medical Ltd (Owner Number: 10023123)

Owner / Operator Contact Address

Unit 7, Upper Slackstead Farm, Farley Lane, Braishfield, Romsey, GB-HAM SO51 0QL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091236

PMA Number

N/A

All Registered Proprietary Names

Neuro20 PRO Xiniwave Medline DeNovo 4Pro Electrical Stimulation Device Mantra TENS Model NT3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-01-19
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-01-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-09-08
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2016-02-24
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2016-02-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2022-09-30
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2022-09-30
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2022-09-30
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2022-09-30
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2022-09-30
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-12-31
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2015-05-01
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2011-01-29
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-09-08

Official Correspondent

No official correspondent registered.

US Agent Details

jay mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

Verity Medical Ltd

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
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

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3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3019892999	CIONIC Facility	Scotts Valley, CA, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019822804. Last updated year: 2026. Please use registration number 3019822804 when referencing this establishment in official correspondence.