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510(k) Data Aggregation

    K Number
    K252767

    Validate with FDA (Live)

    Device Name
    actiTENS mini
    Manufacturer
    Date Cleared
    2026-01-16

    (140 days)

    Product Code
    Regulation Number
    882.5890
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended Use / Indications for Use

    Over-the-counter use:

    actiTENS Mini is intended to be used as:

    Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

    • Symptomatic relief and management of chronic, intractable pain
    • Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
    • Relief of pain associated with arthritis

    Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.

    Prescription use:

    actiTENS Mini is intended to be used as:

    Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

    • Symptomatic relief and management of chronic, intractable pain
    • Adjunctive treatment for post-surgical and post-trauma acute pain
    • Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
    • Relief of pain associated with arthritis

    Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.

    Electrical Muscle Stimulation (EMS), used for the following indications:

    • Temporary relaxation of muscle spasms
    • Prevent or retard disuse atrophy
    • Increase of local blood flow in the treatment area
    • Re-educate muscles
    • Maintain or increase the range of motion
    • Prevention of venous thrombosis of the calf muscles immediately after surgery

    Program P9 corresponds to EMS mode.

    Device Description

    The actiTENS mini is a connected medical device for transcutaneous electrical nerve stimulation (TENS) intended to treat pain in adults. It also contains an electrical muscle strengthening (EMS) program. It is intended for people over 22 years of age with unimpaired intellectual abilities. The actiTENS mini is fixed directly on the body using a fastening accessory. It adapts to the shape of the body with its flexible design. The actiTENS mini can be used discreetly during daily activities.

    The EIG (electrical impulse generator) generates electrical impulses that are diffused in the body through skin electrodes connected to one or two channels via cables available in various lengths. Managing the EIG is done by means of the actiTENS Mobile App that allows users to control the stimulation session by choosing: a stimulation program, the number of channels used, the stimulation intensity for each channel and the stimulation duration.

    AI/ML Overview

    N/A

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