BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PlayMakar Therapeutic Wearable System

    Reg #: 3010632563 · FEI: 3010632563 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    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
    K161453

    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
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN

    Proprietary Names

    PlayMakar Therapeutic Wearable System iReliev Therapeutic Wearable System, model ET-5050 iReliev Expandable Wireless Pods, model ET-5555 iReliev Therapeutic Wearable System with Case, model ET-5050-2 PlayMakar PRO Muscle Stimulator, Model # PRO-1000 and PRO-1000-2 iReliev PlayMakar Black Wireless TENS and EMS Therapeutic Wearable System Muscle Stimulator, IR-PRO-1000, 850030921420

    Establishment Types

    Repack or Relabel Medical Device