Data / Medical devices / Taiwan / Hivox Biotek Inc.
Hivox Biotek Inc.: FDA-registered device maker in New Taipei City, Taiwan, 12 510(k) clearances
Hivox Biotek Inc. is registered with the FDA (registration 9611558) in New Taipei City, Taiwan. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611558
- FEI number
- 3003255512
- Address
- 5 F., NO. 123, Xingde Road Sanchong District, New Taipei City, Taiwan, 24158
- Owner or operator
- HIVOX BIOTEK, INC. (9044329)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 21, 2002
- Registered through
- 2026
- Brand names listed
- 3-in-1 TENS/EMS device with heat, Abs Muscle Trainer, Model: WE-120, Arm & Leg Muscle Trainer, Model: WE-110, Electric Stimulator OTC TENS, Pennypad 904, 907, 909, Flowkeeper, HIVOX, HIVOX OTC Electrical Stimulator, HIVOX OTC Electrical Stimulator, EM59-1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 17, 2024 | K242815 | POCKET TENS (EP-300) | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| October 5, 2023 | K232675 | Heating Tens, FT-615 | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| May 13, 2023 | K223308 | HEATING TENS/EMS, FT-810R | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| October 15, 2021 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| March 10, 2021 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| November 8, 2019 | K192264 | HIVOX Spopad EMS SP-911, SP-921 | NGX | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| November 29, 2017 | K171803 | HIVOX OTC Electrical Stimulator | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| April 6, 2017 | K160323 | FlowKeepers | NGX | Substantially Equivalent | Dk Electronics, LLC | accessdata.fda.gov |
| January 16, 2015 | K141921 | HIVOX SPOPAD EMS | NGX | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| July 25, 2014 | K131720 | HIVOX SELF ADHESIVE ELECTRODE GEL PADS | GXY | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| March 19, 2012 | K112392 | HIVOX BIOTEK INC. | NUH | Substantially Equivalent | Hivox Biotek, Inc. | 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 |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Pad, Heating, Powered
- All makers of Media, Electroconductive
- All makers of Electrode, Cutaneous
- All makers of Massager, Therapeutic, Electric
Updated December 17, 2024. 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.