Prescription Starter Kit for HCP Offices (includes 1 Device, 2 Packs of Quell Electrodes with UDI 00851221006018, 1 Charger, 1 Charger Cable, 1 Sport Band)


Product Overview

Prescription Starter Kit for HCP Offices (includes 1 Device, 2 Packs of Quell Electrodes with UDI 00851221006018, 1 Charger, 1 Charger Cable, 1 Sport Band)
QUELL FIBROMYALGIA - QE-FMP


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: QSQ

    Device Name: Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

    Device Class: 2

    Physical State: Electrical stimulation unit with leads and cutaneous electrodes.

    Definition: Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.

    Submission Type ID: 1

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Applies an electrical current through electrodes on patient's skin.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Sensory nerves

    Regulation Number: 882.5888

    Third Party Flag: N

    Medical Specialty: NE


    Device Identifiers

    Device Id: 00851221006650

    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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