BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iReliev Pads & Leads Refill Kit

    Reg #: 3010632563 · FEI: 3010632563 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EXCELHEALTH INC.
    Registration Number
    3010632563
    FEI Number
    3010632563
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5825 Park Vista Circle
    City
    Fort Worth
    State
    TX
    ZIP
    76244
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082065

    Owner / Operator

    Firm Name
    ExcelHealth Inc.
    Operator Number
    10045721
    Address
    5825 Park Vista Circle
    City
    Fort Worth
    State
    TX
    Postal Code
    76244
    Country
    US
    Correspondent
    Mike Williams

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    iReliev Pads & Leads Refill Kit iReliev Electrode Pads iReliev Small Single Pads Refill Kit, model ET-5151-3 iReliev Large Single Pads Refill Kit, model ET-5454 iReliev Super Pads Refill Kit, model ET-7171 iReliev Large and Small Pads Refill Kit, model ET-8484 iReliev Wireless Large and Small Pads Refill Kit, model ET-5054 PlayMakar Self Adhering Electrode Pads PRO-1004, PRO-504 PlayMakar Self Adhering Electrode Pads

    Establishment Types

    Repack or Relabel Medical Device