BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    THERANICA BIO-ELECTRONICS LTD.

    Reg #: 3015379717 · FEI: 3015379717 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    THERANICA BIO-ELECTRONICS LTD.
    Registration Number
    3015379717
    FEI Number
    3015379717
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4 Ha-Omanut st,
    City
    Netanya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K232152

    Owner / Operator

    Firm Name
    Theranica Bio-Electronics LTD.
    Operator Number
    10060818
    Address
    4 Ha-Omanut st.
    City
    Netanya
    State
    IL-NOTA
    Postal Code
    4250438
    Country
    IL
    Correspondent
    Dagan Harris

    US Agent

    Business Name
    Theranica USA Inc.
    Contact Name
    John Avery
    Address
    100 Somerset Corporate Blvd
    City
    Bridgewater
    State
    NJ
    ZIP
    08807
    Country
    US
    Email
    [email protected]
    Phone
    508 8188394

    Products

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

    Proprietary Names

    NerivioInfinity Nerivio Infinity Nerivio Nerivio / Nerivio Infinity Nerivio / Neerivio Infinity

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Repack or Relabel Medical Device