BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Pure Enrichment PUREPULSE™ GO WIRELESS TENS THERAPY + HEAT, model: PETNHTPR

    Reg #: 9611558 · FEI: 3003255512 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HIVOX BIOTEK INC.
    Registration Number
    9611558
    FEI Number
    3003255512
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 F., NO. 123, Xingde Road, Sanchong District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K223308

    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, Nerve, Transcutaneous, Over-The-Counter NUH
    Pad, Heating, Powered IRT

    Proprietary Names

    Pure Enrichment PUREPULSE™ GO WIRELESS TENS THERAPY + HEAT, model: PETNHTPR

    Establishment Types

    Manufacture Medical Device