BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TheraPearl Koala

    Reg #: 3011015568 · FEI: 3011015568 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RB Health (US) LLC
    Registration Number
    3011015568
    FEI Number
    3011015568
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    399 Interpace Parkway
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US

    Owner / Operator

    Firm Name
    RB Health (US) LLC
    Operator Number
    9004884
    Address
    399 Interpace Parkway
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US
    Correspondent
    Andrew - Alum

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    TheraPearl Koala TheraPearl Rabbit TheraPearl Unicorn TheraPearl Neck Wrap (blue, color changing) TheraPearl Shoulder Wrap with Strap (blue, color changing) TheraPearl Shin Wrap with Strap (blue, color changing) TheraPearl Build Your Own Pack TheraPearl Puppy TheraPearl Husky TheraPearl Ankle/Wrist Wrap with Strap (blue, color changing) TheraPearl Fox TheraPearl Knee Wrap with Strap (blue, color changing) TheraPearl Square (blue, color changing) TheraPearl Back Wrap with Strap (blue, color changing) TheraPearl Shark TheraPearl Pig TheraPearl Pony TheraPearl Round TheraPearl Panda TheraPearl Sports Pack with Strap (blue, color changing) TheraPearl Face Mask (blue, color changing) TheraPearl Oval TheraPearl Dragon TheraPearl Penguin TheraPearl Frog TheraPearl Sports Pack (blue, color changing) TheraPearl Eye Mask (blue, color changing, pink)

    Establishment Types

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