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510(k) Data Aggregation

    K Number
    K181645
    Device Name
    StimaWELL 120MTRS
    Manufacturer
    Date Cleared
    2020-08-13

    (783 days)

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

    Pierenkemper GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS mode: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-tramautic acute pain and post surgical pain Russian mode: - Temporary relaxation of muscle spasms in back area - Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles
    Device Description
    The StimaWELL 120MTRS has been designed for the use of medium frequency electro-therapy for muscle stimulation and pain relief therapy as well as for the warming and wellness application in the back region. The device consists of a 12 channel (electrodes) Stimulation Mat, a Controller and a Remote Control Unit. Various accessories (see 11.3.2 below) support the StimaWELL. The warming is provided through controlled resistive heating of the stimulation mat. Interaction with the device is via a touchscreen on the controller. Selection and set-up of various treatment sequences is via the controller touchscreen or can be recalled from chip cards. The patient can interact with the device by using the remote control unit. With that he can pause the treatment at any time and also adjust the overall intensity.
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