BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FOCUS HEALTH GROUP

    Reg #: 3006802076 · FEI: 3006802076 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    FOCUS HEALTH GROUP
    Registration Number
    3006802076
    FEI Number
    3006802076
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5802 Kingston Pike
    City
    Knoxville
    State
    TN
    ZIP
    37919
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160022

    Owner / Operator

    Firm Name
    Focus Health Group
    Operator Number
    10060699
    Address
    5802 Kingston Pike
    City
    Knoxville
    State
    TN
    Postal Code
    37919
    Country
    US
    Correspondent
    Elizabeth Wilson

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO
    Wound Dressing With Animal-Derived Material(S) KGN
    Dressing, Compression MHW
    Bladder Irrigation Kit PPA
    Dressing, Wound, Hydrophilic NAC
    First Aid Kit With Drug LRR
    Closure, Wound, Adhesive MGO
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Dressing, Wound, Occlusive NAD

    Proprietary Names

    ZeniFoam-AG Gentle ZeniFIBER AG ZeniCol Particles 1gram ZeniCol ZeniCol Collagen Particles Sub Occipital Bandage ZeniFoam-Ag ZeniCol Collagen Dressing ZeniFiber ZeniAbsorb ZeniABSORB Border Plus Epinephrine Professional ZeniGAUZE Gentle Border ZeniCol AG ZeniFoam-Ag Gentle Border ZeniFoam Gentle Border AG ZENIGEL-AG Silver Amorphous Wound Gel ZeniGEL AMORPHOUS HYDROGEL ZeniPad Plus ZeniFoam ZeniPlast ZeniContact ZeniFoam Gentle Border ZeniFoam Gentle

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility