BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioWave GO Rx

    Reg #: 1000655158 · FEI: 1000655158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pivot International
    Registration Number
    1000655158
    FEI Number
    1000655158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11030 Strang Line Rd
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210202

    Owner / Operator

    Firm Name
    Pivot International Inc
    Operator Number
    10043496
    Address
    11030 Strang Line Rd.
    City
    Lenexa
    State
    KS
    Postal Code
    66215
    Country
    US

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ

    Proprietary Names

    BioWave GO Rx

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)