BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIG HEALTH INC

    Reg #: 3024442350 · FEI: 3024442350 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BIG HEALTH INC
    Registration Number
    3024442350
    FEI Number
    3024442350
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2067 Port Bristol Cir
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233577

    Owner / Operator

    Firm Name
    Big Health
    Operator Number
    10088537
    Address
    2067 Port Bristol Cir
    City
    Newport Beach
    State
    CA
    Postal Code
    92660
    Country
    US
    Correspondent
    Reuben Lawson

    Products

    Device Name Product Code
    Computerized Behavioral Therapy Device For Insomnia QVO
    Computerized Behavioral Therapy Device For Anxiety Disorders SCP

    Proprietary Names

    SleepioRx DaylightRx

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device