BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NormaTec Pulse Pro Rx 2

    Reg #: 3003619590 · FEI: 3003619590 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NORMATEC INDUSTRIES, LP
    Registration Number
    3003619590
    FEI Number
    3003619590
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    480 Pleasant Street, Suite A200
    City
    Watertown
    State
    MA
    ZIP
    02472
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183328

    Owner / Operator

    Firm Name
    NORMATEC INDUSTRIES, LP
    Operator Number
    9048130
    Address
    480 Pleasant Street, Suite A200
    City
    Watertown
    State
    MA
    Postal Code
    02472
    Country
    US
    Correspondent
    Gilad - JACOBS

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    NormaTec Pulse Pro Rx 2 NormaTec Pulse Rx 2 Normatec 2 Pro Rx Normatec 2 Rx

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility