BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ActiPatch® Model 077

    Reg #: 3004837702 · FEI: 3005550216 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BIOELECTRONICS CORPORATION
    Registration Number
    3004837702
    FEI Number
    3005550216
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4539 Metropolitan Court
    City
    Frederick
    State
    MD
    ZIP
    21704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192234

    Owner / Operator

    Firm Name
    BioElectronics Corporation
    Operator Number
    10028114
    Address
    4539 Metropolitan Court
    City
    Frederick
    State
    MD
    Postal Code
    21704
    Country
    US
    Correspondent
    Zoya Atiq

    Products

    Device Name Product Code
    Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain PQY

    Proprietary Names

    ActiPatch® Model 077 ActiPatch® Model 088

    Establishment Types

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