BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STIMEL-03 Electrical Stimulator with Biofeedback

    Reg #: 3013508647 · FEI: 3013508647 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ReShape Lifesciences
    Registration Number
    3013508647
    FEI Number
    3013508647
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7625 Golden Triangle Dr Ste G
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130424

    Owner / Operator

    Firm Name
    ReShape Lifesciences
    Operator Number
    10038397
    Address
    7625 Golden Triangle Drive, Suite G
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Alyssa James

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    STIMEL-03 Electrical Stimulator with Biofeedback

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198