BEUDAMED
    FDA Registration Active 🇺🇸 United States

    E-GLOVE, E-STOCKING, E-SLEEVE, E-SOCK

    Reg #: 1055808 · FEI: 1000110974 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    PRIZM MEDICAL, INC.
    Registration Number
    1055808
    FEI Number
    1000110974
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    940 Sherwin Pkwy, Suite 100
    City
    Buford
    State
    GA
    ZIP
    30518
    Country
    US

    Regulatory Submissions

    510(k) Number
    K944487

    Owner / Operator

    Firm Name
    PRIZM MEDICAL, INC.
    Operator Number
    9005746
    Address
    940 Serwin Parkway, Suite 100
    City
    Buford
    State
    GA
    Postal Code
    30518
    Country
    US
    Correspondent
    Jim Johnson

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    E-GLOVE, E-STOCKING, E-SLEEVE, E-SOCK ELECTRO-MESH: GLOVE, SOCK, SLEEVE, WRAP & PANELS SILVER-THERA: GLOVE, SOCK, STOCKING & KNEE

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device