BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CIONIC Facility

    Reg #: 3019892999 · FEI: 3019892999 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    3

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    Registration Details

    Registration Name
    CIONIC Facility
    Registration Number
    3019892999
    FEI Number
    3019892999
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1500 Green Hills Rd, Suite 109
    City
    Scotts Valley
    State
    CA
    ZIP
    95066
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243828

    Owner / Operator

    Firm Name
    CIONIC
    Operator Number
    10082455
    Address
    1500 Green Hills Rd, STE 109
    City
    Scotts Valley
    State
    CA
    Postal Code
    95066
    Country
    US
    Correspondent
    Domenico Pisaturo

    Products

    Device Name Product Code
    Stimulator, Neuromuscular, External Functional GZI
    Stimulator, Muscle, Powered IPF
    Device, Biofeedback HCC

    Proprietary Names

    Cionic Neural Sleeve NS-200 Cionic Neural Sleeve NS-100

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Remanufacture Medical Device Manufacture Medical Device