# Hivox Biotek, Inc.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 18 (2002–2026): 18 510(k) clearances
- Product codes: NUH (11), NGX (3), GZJ (2), GXY (1), FLL (1)
- 510(k) review time since 2016: median 92 days, against 146 for FDA's reviews in the same codes and years (7 of 10 faster)
- Predicates its devices cite: 23 (9 its own); citations of its devices by later devices: 27 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Well-Life Healthcare Limited: 2 (https://510kreport.com/company/well-life-healthcare)
- Top-Rank Health Care Equipment Co., Ltd.: 2 (https://510kreport.com/company/top-rank-health-care-equipment)
- Jkh Health Co., Ltd.: 2 (https://510kreport.com/company/jkh-health)
- Medihightec Medical Co., Ltd.: 1 (https://510kreport.com/company/medihightec-medical)
- Sport-Elec: 1 (https://510kreport.com/company/sport-elec)
- Axelgaard Mfg. Co., Ltd.: 1 (https://510kreport.com/company/axelgaard-mfg)
- Shenzhen Dongdixin Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-dongdixin-technology)
- Tyece, Ltd.: 1 (https://510kreport.com/company/tyece)

## Firms that cite its devices most
- Shenzhen Yicai Health Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-yicai-health-technology)
- Progenix, LLC: 2 (https://510kreport.com/company/progenix)
- Shenzhen Jian Feng Electronic Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-jian-feng-electronic-technology)
- Guandong Skg Intelligent Technology Co., Ltd.: 1 (https://510kreport.com/company/guandong-skg-intelligent-technology)
- Prospera Corporation: 1 (https://510kreport.com/company/prospera)
- Well-Life Healthcare Limited: 1 (https://510kreport.com/company/well-life-healthcare)
- Nu-Beca & Maxcellent Co.: 1 (https://510kreport.com/company/nu-beca-maxcellent)
- Dk Electronics, LLC: 1 (https://510kreport.com/company/dk-electronics)

## Its most-cited devices
- K171803: HIVOX OTC Electrical Stimulator (2017), cited by 11
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), cited by 4
- K190347: HIVOX OTC Electrical Stimulator (2019), cited by 3
- K211403: HIVOX OTC Electrical Stimulator, FT610-B (2021), cited by 3
- K140650: Hivox Electric Stimulator Otc Tens (2014), cited by 2
- K112392: Hivox Biotek Inc. (2012), cited by 2

## Recent decisions
- K260425: TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) (Jun 16, 2026)
- K242815: Pocket Tens (EP-300) (Dec 17, 2024)
- K232675: Heating Tens, FT-615 (Oct 5, 2023)
- K223308: Heating Tens/Ems, FT-810R (May 13, 2023)
- K221384: Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 (Jun 11, 2022)
- K211403: HIVOX OTC Electrical Stimulator, FT610-B (Oct 15, 2021)
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (Mar 10, 2021)
- K192264: HIVOX Spopad EMS SP-911, SP-921 (Nov 8, 2019)

Source page: https://510kreport.com/company/hivox-biotek