BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NORMATEC INDUSTRIES, LP

    Reg #: 3003619590 · FEI: 3003619590 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NORMATEC INDUSTRIES, LP
    Registration Number
    3003619590
    FEI Number
    3003619590
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    480 Pleasant Street, Suite A200
    City
    Watertown
    State
    MA
    ZIP
    02472
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183169

    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
    Massager, Powered Inflatable Tube IRP
    Sleeve, Limb, Compressible JOW
    Pad, Heating, Powered IRT
    Pack, Hot Or Cold, Water Circulating ILO

    Proprietary Names

    NormaTec Pulse Pro 2 NormaTec Pulse 2 Normatec 2 Normatec 2 Pro Normatec Elite Hip NormaTec PCD Normatec Elite Normatec 3 NormaTec Pulse Rx 2 NormaTec Pulse Pro Rx 2 Normatec 2 Pro Rx Normatec 2 Rx Hyperice X Hyperice X 2 NormaTec WavePlus NormaTec Wave NormaTec MVP Normatec Go NormaTec Pulse Pro NormaTec Pulse

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility