BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VibraCool® Plantar

    Reg #: 3007439125 · FEI: 3007439125 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Pain Care Labs
    Registration Number
    3007439125
    FEI Number
    3007439125
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    195 ARIZONA AVE LW08
    City
    Atlanta
    State
    GA
    ZIP
    30307
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202993

    Owner / Operator

    Firm Name
    MMJ Labs dba Pain Care Labs
    Operator Number
    10027555
    Address
    195 Arizona Ave., LW08
    City
    Atlanta
    State
    GA
    Postal Code
    30307
    Country
    US
    Correspondent
    Amy L Baxter

    Products

    Device Name Product Code
    Cold Pack And Vibrating Massager PHW
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    VibraCool® Plantar Buzzy® Mini Healthcare VibraCool® Easy Fit Buzzy® XL Personal Buzzy® Pro VibraCool® Pro Lower Extremity (LE) VibraCool® Pro Healthcare VibraCool® Pro Durable Medical Equipment (DME) Buzzy® Mini Personal Buzzy® Healthcare VibraCool® Flex VibraCool® Pro Upper Extremity (UE) VibraCool® Extended Buzzy® LadyBuzz

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility