BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HAPPY HEALTH

    Reg #: 3033715634 · FEI: 3033715634 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    9

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    Registration Details

    Registration Name
    HAPPY HEALTH
    Registration Number
    3033715634
    FEI Number
    3033715634
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3200 Gracie Kiltz Ln Ste 301
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240236

    Owner / Operator

    Firm Name
    Happy Health
    Operator Number
    10091422
    Address
    3200 Gracie Kiltz Ln., Ste. 301
    City
    Austin
    State
    TX
    Postal Code
    78758
    Country
    US
    Correspondent
    David Carr

    Products

    Device Name Product Code
    Oximeter DQA
    Device, Galvanic Skin Response Measurement GZO
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Breathing Frequency BZQ
    Continuous Measurement Thermometer FLL
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Device, Sleep Assessment LEL
    Reduced- Montage Standard Electroencephalograph OMC
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Happy Ring Health Monitoring System Happy Health Home Sleep Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device