BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THERANICA USA

    Reg #: 3015549449 · FEI: 3015549449 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    THERANICA USA
    Registration Number
    3015549449
    FEI Number
    3015549449
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    100 Somerset Corporate Blvd, 2nd Fl, Ste 160
    City
    Bridgewater
    State
    NJ
    ZIP
    08807
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250405

    Owner / Operator

    Firm Name
    Theranica USA
    Operator Number
    10060939
    Address
    100 Somerset Corporate Blvd., 2nd Fl, Suite 160
    City
    Bridgewater
    State
    NJ
    Postal Code
    08807
    Country
    US
    Correspondent
    John Avery

    Products

    Device Name Product Code
    Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine QGT

    Proprietary Names

    Nerivio Infinity Nerivio Infinity refill unit Nerivio

    Establishment Types

    Repack or Relabel Medical Device