Consumer Starter Kit, eCommerce (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 charger cable, 1 sport band)


Product Overview

Consumer Starter Kit, eCommerce (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 charger cable, 1 sport band)
QUELL 2.0 - QE-NAS


Device Description

An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 70.00
    • -25.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NUH

    Device Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter

    Device Class: 2

    Physical State: N/A

    Definition: TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

    Submission Type ID: 1

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 882.5890

    Third Party Flag: Y

    Medical Specialty: NE


    Device Identifiers

    Device Id: 00851221006469

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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