Data / Medical devices / Taiwan / Gemore Technology Co., Ltd.
Gemore Technology Co., Ltd.: FDA-registered device maker in TAN SHUI New Taipei, Taiwan, 16 510(k) clearances
Gemore Technology Co., Ltd. is registered with the FDA (registration 3004146401) in TAN SHUI New Taipei, Taiwan. It lists 12 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004146401
- Address
- 11 FL, No. 29-5, Sec. 2 Chung Cheng E. RD., TAN SHUI New Taipei, Taiwan, 251
- Owner or operator
- GEMORE TECHNOLOGY CO., LTD. (9058370)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- July 28, 2004
- Registered through
- 2026
- Brand names listed
- 310PE,320PE,330PE,340PE,and 350PE, Brace, GEM-STIM TENS,Models GM3XY & GM3AXY, GEM-THERMO PAD, GEM-TONE Body Training System, GEM-TRACTION, GEM-TWIN TENS / MODELS GM3XY/Z, GEMORE HEATING PAD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | HST | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Interferential Current Therapy | LIH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Exporter to the US | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | 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 |
|---|---|---|---|---|---|---|
| August 16, 2019 | K190988 | GIM-STIM OTC TENS/EMS System | NUH | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| May 12, 2015 | K150681 | GEMORE OTC TENS | NUH | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| December 21, 2012 | K122948 | GEM-STIM COMBO STIMULATOR | GZJ | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| December 21, 2012 | K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | LIH | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| July 20, 2012 | K120569 | GEMORE TENS SYSTEM | GZJ | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| September 2, 2011 | K102933 | GEM-TONE BODY TRAINING SYSTEM | NGX | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| August 25, 2011 | K102926 | GEMORE MUSCLE CONDITIONER; | NGX | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| October 16, 2009 | K091833 | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. | NGX | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| June 29, 2007 | K070890 | EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 | LIH | Substantially Equivalent | Everlife Medical Equipment Co., Ltd. | accessdata.fda.gov |
| January 4, 2007 | K062675 | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES | GXY | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| April 28, 2006 | K060222 | LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP | NUH | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| November 17, 2004 | K042559 | GEM-TWIN TENS/ MODELS GM3XY/Z | GZJ | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| December 16, 2003 | K032994 | GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) | GZJ | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| December 10, 2003 | K032720 | GEM-STIM TENS, MODELS GM3XY AND GM3AXY | GZJ | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| December 10, 2003 | K032719 | GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) | LIH | Substantially Equivalent | Gemore Technology Co, Ltd. | accessdata.fda.gov |
| December 2, 2002 | K022494 | HOME CARE JELLY | GYB | Substantially Equivalent | Roc Chinese-European Industrial Research Society | accessdata.fda.gov |
Compare with other makers
- All makers of Joint, Knee, External Brace
- All makers of Interferential Current Therapy
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Massager, Therapeutic, Electric
Updated August 16, 2019. 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.