BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Freespira, Inc

    Reg #: 3010887638 · FEI: 3010887638 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    Freespira, Inc
    Registration Number
    3010887638
    FEI Number
    3010887638
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12020 113th Ave NE, Ste 215
    City
    Kirkland
    State
    WA
    ZIP
    98034
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180173

    Owner / Operator

    Firm Name
    Palo Alto Health Sciences
    Operator Number
    10046775
    Address
    12020 113th Ave NE, 068023986Ste 215
    City
    Kirkland
    State
    WA
    Postal Code
    98034
    Country
    US
    Correspondent
    Simon Thomas

    Products

    Device Name Product Code
    Device, Biofeedback HCC
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety SEN

    Proprietary Names

    Freespira Freespira Breathing System Canary Breathing System

    Establishment Types

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