BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SANUWAVE, INC.

    Reg #: 1062240 · FEI: 3006261799 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    SANUWAVE, INC.
    Registration Number
    1062240
    FEI Number
    3006261799
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9600 W 76th St
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140782

    Owner / Operator

    Firm Name
    SANUWAVE, INC.
    Operator Number
    9083571
    Address
    9600 W 76th St
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US

    Products

    Device Name Product Code
    Generator, Shock-Wave, For Pain Relief NBN
    Massager, Therapeutic, Electric ISA
    Wound Cleaner, Ultrasound NRB

    Proprietary Names

    orthoPACE PACE Applicator for orthoPACE EvoTron EvoTrode Profile by SANUWAVE UltraMIST System

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Repack or Relabel Medical Device