BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Model HL-PB-S Foot & Ankle System

    Reg #: 3012482375 · FEI: 3012482375 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HEALTHLIGHT LLC
    Registration Number
    3012482375
    FEI Number
    3012482375
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    110 Front Street, Suite 300
    City
    Jupiter
    State
    FL
    ZIP
    33477
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163079

    Owner / Operator

    Firm Name
    HealthLight LLC
    Operator Number
    10048439
    Address
    110 Front Street, Suite 300
    City
    Jupiter
    State
    FL
    Postal Code
    33477
    Country
    US

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    Model HL-PB-S Foot & Ankle System Model BT-132-S Medium Pad System (Brain Tap) Model HL-FB-V1 FootBed V.1 Model HL-264-S Large Pad System Model HL-132-S Medium Pad System Model HL-180-S Painbuster II System Model HL-CP-S, Foot and Hand Pad System Model HL-90-S Painbuster System Model HL-PB2-S Dual Foot & Ankle System Model RD-HB-S Headband System (Russell) Model BT-HB-S Headband System (BrainTap) Model HL-HB-S Headband System Model HL-NP2-S Dual Foot & Calf System Model HL-NP-S Foot & Calf System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198