BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Podimetrics Remote Temperature Monitoring System

    Reg #: 3003695829 · FEI: 3003695829 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OnCore Manufacturing
    Registration Number
    3003695829
    FEI Number
    3003695829
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    125 Fisher Street
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150557

    Owner / Operator

    Firm Name
    OnCore Manufacturing LLC
    Operator Number
    10050743
    Address
    125 Fisher Street
    City
    Westborough
    State
    MA
    Postal Code
    01581
    Country
    US
    Correspondent
    John Marcil

    Products

    Device Name Product Code
    Foot Examination Tool For Inflammatory Changes OIZ

    Proprietary Names

    Podimetrics Remote Temperature Monitoring System SmartMat (SKU PMHS201U) Podimetrics Remanufactured SmartMat (SKU PMHS201U) SmartMat (SKU PMHS201U-R) Podimetrics Wi-Fi SmartMat (SKU PMHS230U)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)