Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004146401

FEI Number

3004146401

Entity Name

GEMORE TECHNOLOGY CO., LTD.

City/State/Country

TAN SHUI New Taipei, TW

Establishment Address

11 FL, NO. 29-5, SEC. 2, CHUNG CHENG E. RD., TAN SHUI New Taipei 251, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GEMORE TECHNOLOGY CO., LTD. (Owner Number: 9058370)

Owner / Operator Contact Address

11 FL, NO. 29-5, SEC. 2, CHUNG CHENG E. RD., TAN SHUI, TW-NWT 251, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Brace Home Care Jelly GEM-THERMO PAD GEMORE HEATING PAD ULTRA-THERMO PAD GEMORE TENS System GEM-STIM TENS,Models GM3XY & GM3AXY Massager, Therapeutic, Electric GEMORE REUSABLE SEL GM3 SERIES IF TENS, MODEL GM3X2IF Stimulator, Nerve, Transcutaneous, For Pain Relief LOW BACK PAIN RELIEF SYSTEM GEM-TWIN TENS / MODELS GM3XY/Z IF-100507 GEM-TONE Body Training System GEMORE TRACTION ULTRA-TRACTION GEM-TRACTION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-12-17
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2009-05-25
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2004-07-28
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2012-12-16
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2012-12-16
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-11-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-11-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2009-05-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-03-06
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2007-11-20
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2013-01-02
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-01-02
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2013-01-02
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2007-04-24
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-12-03
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2007-11-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-11-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-11-20
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2010-01-12
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2011-09-09
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2004-07-28

Official Correspondent

BODEN S.P. LAI

US Agent Details

Karen Pellegrino Email: SFLK10@hotmail.com Phone: (561) 3170186

Related Public Records

Same Entity

GEMORE TECHNOLOGY CO., 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004146401. Last updated year: 2026. Please use registration number 3004146401 when referencing this establishment in official correspondence.