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510(k) Data Aggregation

    K Number
    K201458
    Device Name
    Scrambler Therapy Technology (Model ST-5A)
    Date Cleared
    2020-12-23

    (205 days)

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

    **Delta International Services **& Logistics S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General Indications for Use : - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain. - · Symptomatic relief of acute pain. - · Symptomatic relief of post-operative pain.
    Device Description
    The ST-5A is a patented non-invasive electro-analgesia device, with 5 chamels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program. Five artificial neurons create "packets" (strings) of information recognized as "non pain", the content of which is controlled by a proprietary algorithm. This various information of "no pain" produces an immediate analgesic effect, capable of completely eliminating pain in real time. Up to 5 pairs of independent electrodes can be placed on the patient's body based on the need of the treatment. Two microprocessors ensure the correct operation of the device by automatically establishing the optimal parameters of effectiveness and safety, which cannot be modified by the operator. In order to perform the treatment correctly, the operator only needs to position the electrodes and adjust the stimulation levels correctly. The placement of the electrodes requires scrupulous observance of the method of identifying the areas of pain treatment. If the treatment is performed correctly, normally the pain is zeroed (or reduced very close to zero) in real time regardless of the initial intensity and the pathology that generated it.
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    K Number
    K142666
    Device Name
    Scrambler Therapy MC-5 A Device
    Date Cleared
    2015-05-22

    (246 days)

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

    **Delta International Services **& Logistics S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Scrambler Therapy MC-5A Device is indicated for: - Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain. - Symptomatic relief of acute pain. - Symptomatic relief of post-operative pain.
    Device Description
    The Scrambler Therapy MC-5A Device is a multi-channel device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.
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