BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADROIT MEDICAL SYSTEMS, INC.

    Reg #: 1055823 · FEI: 1000111140 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ADROIT MEDICAL SYSTEMS, INC.
    Registration Number
    1055823
    FEI Number
    1000111140
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1146 CARDING MACHINE RD.
    City
    LOUDON
    State
    TN
    ZIP
    37774
    Country
    US

    Regulatory Submissions

    510(k) Number
    K921920

    Owner / Operator

    Firm Name
    ADROIT MEDICAL SYSTEMS, INC.
    Operator Number
    9005173
    Address
    1146 CARDING MACHINE RD., --
    City
    Loudon
    State
    TN
    Postal Code
    37774
    Country
    US
    Correspondent
    KELLEY - PATTEN

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ
    Transducer, Ultrasonic, Diagnostic ITX
    Gown, Examination FME
    Pack, Hot Or Cold, Water Circulating ILO
    Drape, Surgical, Exempt PUI

    Proprietary Names

    Medi-Choice Soft-Temp Soft-Air Sheathing Technologies ThermalX Mistral-Air HTP-1500 Currie Medical

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)