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510(k) Data Aggregation

    K Number
    K200848
    Device Name
    Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
    Manufacturer
    Micron Medical Corporation
    Date Cleared
    2020-08-14

    (136 days)

    Product Code
    GZF
    Regulation Number
    882.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micron Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Moventis PNS is not intended to treat pain in the craniofacial region.
    Device Description
    Moventis PNSTM is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.
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