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510(k) Data Aggregation

    K Number
    K171366
    Device Name
    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
    Manufacturer
    Stimwave Technologies Inc.,DBA StimQ LLC
    Date Cleared
    2017-08-04

    (87 days)

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

    ,DBA StimQ LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StimQ Peripheral Nerve Stimulator (PNS) System 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
    Device Description
    The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System (System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A, Freedom-4A or StimQ), receiver component (Receiver/RF Stylet), and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
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    K Number
    K152178
    Device Name
    StimQ Peripheral Nerve Stimulator (PNS) System
    Manufacturer
    STIMQ LLC
    Date Cleared
    2016-03-11

    (220 days)

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

    STIMQ LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StimQ Peripheral Nerve Stimulator (PNS) System 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
    Device Description
    The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
    Ask a Question

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