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Sign in to claim this brandHIVOX BIOTEK INC.
Taiwan·TW-MF-000052507
Last updated September 17, 2026
Information
- Country
- Taiwan
- Address
- 5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City, Taiwan
- Website
- www.hivox-biotek.com/
- —
- —
- [email protected]
- Phone
- +886 2 85112668
- PRRC Contact
- Derek Tuan
- EUDAMED SRN
- TW-MF-000052507
- FDA FEI Number
- 3003255512
- DUNS Number
- 658030473
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tens Maker | WT-110 | FDA UDI | Class II | Active |
| Tens Maker | WE-201 | FDA UDI | Class II | Active |
| Pure Enrichment | FT-240 | FDA UDI | Class II | Active |
| Tens Maker | WT-110-2 | FDA UDI | Class II | Active |
| Tens Maker | WT-110-RF4 | FDA UDI | Class II | Active |
| Low Frequency Therapeutic Device | 867.27 | EUDAMED | Class IIa | Active |
| HIVOX Spopad EMS SP-911, SP-921 | K192264 | FDA 510(k) | Class II | Active |
| Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 | K221384 | FDA 510(k) | Class II | Active |
| Heating Tens, FT-615 | K232675 | FDA 510(k) | Class II | Active |
| Hivox Spopad Ems | K141921 | FDA 510(k) | Class II | Active |
| Hivox Ear Thermometer, Ts Series | K020471 | FDA 510(k) | Class II | Active |
| HIVOX OTC Electrical Stimulator | K190347 | FDA 510(k) | Class II | Active |
| Hivox Dreamate Dm-800 | K021952 | FDA 510(k) | Class II | Active |
| HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | K203574 | FDA 510(k) | Class II | Active |
| Hivox Electric Stimulator Otc Tens | K140650 | FDA 510(k) | Class II | Active |
| HIVOX OTC Electrical Stimulator | K171803 | FDA 510(k) | Class II | Active |
| Hivox Self Adhesive Electrode Gel Pads | K131720 | FDA 510(k) | Class II | Active |
| Pocket Tens (ep-300) | K242815 | FDA 510(k) | Class II | Active |
| Heating Tens/Ems, Ft-810r | K223308 | FDA 510(k) | Class II | Active |
| Hivox Electric Stimulator Tens & Ems, Hd2 | K092448 | FDA 510(k) | Class II | Active |
| HIVOX OTC Electrical Stimulator, FT610-B | K211403 | FDA 510(k) | Class II | Active |
| EM25 - glute toning device | K143737 | FDA 510(k) | Class II | Active |
| Low Frequency Therapeutic Device | 867.28 | EUDAMED | Class IIa | Active |
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