BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOELECTRONICS CORPORATION

    Reg #: 3004837702 · FEI: 3005550216 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    BIOELECTRONICS CORPORATION
    Registration Number
    3004837702
    FEI Number
    3005550216
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3880 Roundtree Rd Unit 1
    City
    Jefferson
    State
    MD
    ZIP
    21755
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190251

    Owner / Operator

    Firm Name
    BioElectronics Corporation
    Operator Number
    10028114
    Address
    3880 Roundtree Road, Unit 1
    City
    Jefferson
    State
    MD
    Postal Code
    21755
    Country
    US
    Correspondent
    Sankamitra Santhanakrishnan

    Products

    Device Name Product Code
    Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat ILX
    Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain PQY

    Proprietary Names

    RecoveryRx Model 077 RecoveryRx Model 088 ActiPatch® Model 088 ActiPatch® Model 077

    Establishment Types

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