BEUDAMED
    FDA Registration Active 🇵🇭 Philippines

    BioWave GO Rx

    Reg #: 1000655211 · FEI: 1000655211 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pivot Hawks Manila, Inc.
    Registration Number
    1000655211
    FEI Number
    1000655211
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 3-D, Unit 1-3, Greenfield Auto Park SEZ, Barangay Don Jose
    City
    Sta Rosa Laguna
    Country
    PH

    Regulatory Submissions

    510(k) Number
    K210202

    Owner / Operator

    Firm Name
    Pivot International
    Operator Number
    9107199
    Address
    Pivot International, 11030 Strang Line Road
    City
    Lenexa
    State
    KS
    Postal Code
    66215
    Country
    US

    US Agent

    Business Name
    MAE Group
    Contact Name
    Prashant Jadavbhai Vanani
    Address
    250 Commercial Street, Suite 3007
    City
    Manchester
    State
    NH
    ZIP
    03101
    Country
    US
    Email
    [email protected]
    Phone
    603 5540367

    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)