BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DEKA RESEARCH & DEVELOPMENT CORP.

    Reg #: 1220973 · FEI: 1220973 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    DEKA RESEARCH & DEVELOPMENT CORP.
    Registration Number
    1220973
    FEI Number
    1220973
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    340 Commercial St
    City
    Manchester
    State
    NH
    ZIP
    03101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191313

    Owner / Operator

    Firm Name
    DEKA Research & Development Corp.
    Operator Number
    10041884
    Address
    340 Commercial St
    City
    Manchester
    State
    NH
    Postal Code
    03101
    Country
    US
    Correspondent
    Paul Smolenski

    Products

    Device Name Product Code
    Infusion Pump, Drug Specific, Pharmacy-Filled QJY
    Wheelchair, Powered ITI
    Wheelchair, Stair Climbing IMK
    Pump, Infusion FRN
    Alternate Controller Enabled Insulin Infusion Pump QFG
    Calculator, Drug Dose NDC
    Controller, Infusion, Intravascular, Electronic LDR
    Interoperable Automated Glycemic Controller QJI
    Clamp, Tubing, Blood, Automatic FIG
    Insulin Pump Secondary Display PKU
    Set, Administration, Intravascular FPA
    Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography PAE

    Proprietary Names

    iBOT Personal Mobility Device (iBOT PMD) iBOT Volumetric Infusion Controller DEKA TAC Device DEKA Arm System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility