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510(k) Data Aggregation

    K Number
    K223217
    Device Name
    Zynex Monitoring System, Model CM-1600
    Manufacturer
    Zynex Medical, Inc.
    Date Cleared
    2023-06-16

    (242 days)

    Product Code
    DSB, DQA, FLL
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zynex Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients: - Bioelectrical Impedance - ECG Amplitude - PPG Amplitude - Skin Temperature
    Device Description
    The Zynex Monitoring System, Model CM-1600, simultaneously monitors various parameters of a patient's body. These parameters include Bioelectrical Impedance, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature. A Relative Index value is calculated as a combination of the changes in these parameters and is represented by a single number. The CM-1600 System is comprised of two (2) subsystems, the Wearable and the Monitor. The CM-1600 Wearable is designed and developed by Zynex Monitoring Solutions, and it collects physiological parameters and transmits those parameters to the CM-1600 Monitor via wireless communication. The CM-1600 Monitor is a Zynex-branded, third-party all-in-one medical grade tablet.
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    K Number
    K191697
    Device Name
    Cardiac Monitor 1500
    Manufacturer
    Zynex Medical, Inc.
    Date Cleared
    2020-02-21

    (241 days)

    Product Code
    DSB, DQA, FLL
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zynex Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Monitoring of the following parameters and their relative changes, indicative of relative changes in fluid volume in adult patients. - Bioelectrical Impedance - Heart Rate - ECG Amplitude - PPG Amplitude
    Device Description
    Cardiac Monitor, Model 1500 and accessories monitor a patient's parameters. These parameters include: Bioelectrical Impedance, Heart Rate, ECG Amplitude, and Skin Temperature. The Cardiac Monitor, Model 1500, is intended to be used in a professional medical environment such as hospitals, clinics and research institutions. The Cardiac Monitor, Model 1500, is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance by the operator. The user of the Cardiac Monitor, Model 1500, shall be a qualified operator. The operator shall have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.
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    K Number
    K121820
    Device Name
    INWAVE
    Manufacturer
    ZYNEX MEDICAL, INC.
    Date Cleared
    2012-08-24

    (64 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYNEX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.
    Device Description
    Non-Implanted Electrical Continence Device, Model InWave.
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    K Number
    K111279
    Device Name
    NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
    Manufacturer
    ZYNEX MEDICAL, INC.
    Date Cleared
    2011-09-20

    (138 days)

    Product Code
    IPF, GZJ, LIH
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYNEX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential Mode (IFC) - . Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. Neuromuscular Electrical Stimulation Mode (NMES) - . Muscle Re-education - . Prevention or Retardation of Disuse Atrophy - . Increasing Local Blood Circulation - . Maintaining or Increasing Range of Motion - . Relaxation of Muscle Spasms Transcutaneous Electrical Nerve Stimulation Mode (TENS) - . Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.
    Device Description
    Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.
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