2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.


Product Overview

2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re
Aleve - 1613579


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

  • Handling Environment Temperature - Degrees Fahrenheit
    • N/A
    • -4.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 149.00
    • N/A
  • Storage Environment Temperature - Degrees Fahrenheit
    • 85.00
    • N/A

  • 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: 00325866564948

    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


    Device Id: 10325866564945

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00325866564948

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: Not in Commercial Distribution

    Package Type: N/A


    Device Id: 10325866572445

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00325866564948

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: Not in Commercial Distribution

    Package Type: N/A


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