BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DT7314 TENS 7000 Massage (ASIN B0DWKMKTXD)

    Reg #: 3012316249 · FEI: 3012316249 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    COMPASS HEALTH BRANDS (CORPORATE OFFICE)
    Registration Number
    3012316249
    FEI Number
    3012316249
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6753 Engle Rd
    City
    Middleburg Heights
    State
    OH
    ZIP
    44130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130802

    Owner / Operator

    Firm Name
    Compass Health Brands (Corporate Office)
    Operator Number
    2182780
    Address
    6753 Engle Rd
    City
    Middleburg Heights
    State
    OH
    Postal Code
    44130
    Country
    US
    Correspondent
    Elizabeth Proctor

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    DT7314 TENS 7000 Massage (ASIN B0DWKMKTXD) DT7310 TENS 7000 Sport Massage +EMS (ASIN B0DWKLNDJ6) DT7309 TENS 7000 Massage + EMS (ASIN B0DWKL6T6Z)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198