BEUDAMED
    FDA Registration Active 🇫🇷 France

    actiTENS Android app

    Reg #: 3015588280 · FEI: 3015588280 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    SUBLIMED
    Registration Number
    3015588280
    FEI Number
    3015588280
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    137 Rue Mayoussard
    City
    Moirans Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K202159

    Owner / Operator

    Firm Name
    SUBLIMED
    Operator Number
    10088953
    Address
    137 Rue Mayoussard
    City
    Moirans
    State
    Auvergne-Rhone-Alpes
    Postal Code
    38380
    Country
    FR
    Correspondent
    Adrien HALLET

    US Agent

    Business Name
    Medical Device Academy Incorporated
    Contact Name
    Robert Packard
    Address
    345 Lincoln Hill Rd
    City
    Cuttingsville
    State
    VT
    ZIP
    05738
    Country
    US
    Email
    [email protected]
    Phone
    802 2581881

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    actiTENS Android app Charging Case spare actiTENS iOs app actiTENS Standard Kit self-adhesive strip actiTENS spare

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device