FDA Registration
Active
🇹🇼 Taiwan
GEMORE TECHNOLOGY CO., LTD.
Reg #: 3004146401
·
FEI: 3004146401
·
Expires 2026
Products
12
Proprietary Names
23
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- GEMORE TECHNOLOGY CO., LTD.
- Registration Number
- 3004146401
- FEI Number
- 3004146401
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11 FL, NO. 29-5, SEC. 2, CHUNG CHENG E. RD.
- City
- TAN SHUI New Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K022494
Owner / Operator
- Firm Name
- GEMORE TECHNOLOGY CO., LTD.
- Operator Number
- 9058370
- Address
- 11 FL, NO. 29-5, SEC. 2, CHUNG CHENG E. RD.
- City
- TAN SHUI
- State
- New Taipei
- Postal Code
- 251
- Country
- TW
- Correspondent
- BODEN S.P. LAI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2012-12-17 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2009-05-25 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2004-07-28 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2012-12-16 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2012-12-16 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2007-11-20 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2009-05-27 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2007-03-06 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2007-11-20 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2007-04-24 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2011-09-09 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2004-07-28 |
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
310PE,320PE,330PE,340PE,and 350PE
Interferential Current Therapy
GM3 SERIES HV TENS, MODEL GM3X3HV
Gemore Muscle Conditioner
Gemore Technology Co., Ltd.
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device