BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    HIVOX BIOTEK INC.

    Reg #: 9611558 · FEI: 3003255512 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    HIVOX BIOTEK INC.
    Registration Number
    9611558
    FEI Number
    3003255512
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 F., NO. 123, Xingde Road, Sanchong District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K192264

    Owner / Operator

    Firm Name
    HIVOX BIOTEK, INC.
    Operator Number
    9044329
    Address
    5 F., NO. 123, Xingde Road, Sanchong District
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    24158
    Country
    TW

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Pad, Heating, Powered IRT
    Electrode, Cutaneous GXY
    Media, Electroconductive GYB
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Hivox Pure Enrichment PUREPULSE™ GO WIRELESS TENS THERAPY + HEAT, model: PETNHTPR HIVOX OTC Electrical Stimulator, EM59-2 HIVOX OTC Electrical Stimulator, EM59-1 3-in-1 TENS/EMS device with heat Pain Pad relief, Model: WT-110 Electric Stimulator OTC TENS, Pennypad 904, 907, 909 HIVOX OTC Electrical Stimulator SELF ADHESIVE ELECTRODE GEL PADS HIVOX Reusable Self Adhesive Electrode SP910 SP920 SP620 Abs Muscle Trainer, Model: WE-120 Arm & Leg Muscle Trainer, Model: WE-110 HIVOX Flowkeeper Messager, model SP-900

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility