GWALIA HEALTHCARE LIMITED

FDA Device Registration & Listing · PONTYPRIDD Wales, GB · Registration 3016670292

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016670292
FEI Number
3016670292
Entity Name
GWALIA HEALTHCARE LIMITED
City/State/Country
PONTYPRIDD Wales, GB
Establishment Address
TAFFS MEAD ROAD, TREFOREST INDUSTRIAL ESTATE, PONTYPRIDD Wales CF375TF, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GWALIA HEALTHCARE LIMITED (Owner Number: 10063423)
Owner / Operator Contact Address
TAFFS MEAD ROAD, TREFOREST INDUSTRIAL ESTATE, PONTYPRIDD, GB-WLS CF375TF, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FIREFLY T-1 geko W-2 geko T-2; geko T-3 Firefly T-2 geko T-2 geko T-3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2020-03-20
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2020-03-20
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-08-27
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2020-11-24
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2020-03-20
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2020-03-20

Official Correspondent

Vicki Griffiths

US Agent Details

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

Related Public Records

Same Entity

GWALIA HEALTHCARE 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
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016670292. Last updated year: 2026. Please use registration number 3016670292 when referencing this establishment in official correspondence.
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