BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Polar Care Wave

    Reg #: 2028253 · FEI: 1000125378 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BREG, INC.,
    Registration Number
    2028253
    FEI Number
    1000125378
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2382 Faraday Avenue, Suite 300
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183702

    Owner / Operator

    Firm Name
    Breg Inc
    Operator Number
    10041297
    Address
    2382 Faraday Avenue, Suite 300
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Monique Zamora

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Water Circulating ILO
    Massager, Powered Inflatable Tube IRP

    Proprietary Names

    Polar Care Wave Transformer Cold Compression Pad Y-Adapter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility