BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hypertec HCM LLC

    Reg #: 3013896610 · FEI: 3013896610 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    Hypertec HCM LLC
    Registration Number
    3013896610
    FEI Number
    3013896610
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1570 Perry Road
    City
    Plainfield
    State
    IN
    ZIP
    46168
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170723

    Owner / Operator

    Firm Name
    Hypertec HCM LLC
    Operator Number
    10053193
    Address
    1570 Perry Rd
    City
    Plainfield
    State
    IN
    Postal Code
    46168
    Country
    US
    Correspondent
    John Pichon

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    System, Test, Blood Glucose, Over The Counter NBW
    Device, Sleep Assessment LEL
    Monitor, Breathing Frequency BZQ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Oximeter DQA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Device, Galvanic Skin Response Measurement GZO
    System, Network And Communication, Physiological Monitors MSX
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Spirometer, Diagnostic BZG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Calculator/Data Processing Module, For Clinical Use JQP
    Scale, Stand-On, Patient FRI
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph Software For Over-The-Counter Use QDA
    Electrocardiograph DPS
    Medical Device Data System OUG

    Proprietary Names

    No Proprietary Name

    Establishment Types

    Repack or Relabel Medical Device