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510(k) Data Aggregation

    K Number
    K202159
    Device Name
    actiTENS
    Manufacturer
    Date Cleared
    2020-12-22

    (141 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sublimed

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    actiTENS 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 and P13 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
    actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
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