Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.


Product Overview

Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2
Aleve - 1613538


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 Atmospheric Pressure - millibar
    • 1060.00
    • 500.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 30.00
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • 10.00

  • 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: 10325866565041

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00325866565044

    Package Quantity: 1

    Package Discontinue Date: 5/13/2019 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: N/A


    Device Id: 00325866565044

    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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