LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K222443
    Device Name
    Air Smart Extra Spirometer
    Manufacturer
    FeelLife Health Inc.
    Date Cleared
    2023-08-09

    (362 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    FeelLife Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The spirometer (Air Smart Extra) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.
    Device Description
    Not Found
    Ask a Question
    K Number
    K182906
    Device Name
    Portable Mesh Nebulizer
    Manufacturer
    FeelLife Health Inc.
    Date Cleared
    2020-09-27

    (711 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FeelLife Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. It is not intended for use with Pentamidine.
    Device Description
    Vibrating Mesh Nebulizer System
    Ask a Question

    Page 1 of 1