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510(k) Data Aggregation

    K Number
    K160255
    Device Name
    HBOTC Muscle and Nerve Stimulator
    Manufacturer
    Date Cleared
    2016-09-15

    (227 days)

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

    HB MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Transcutaneous Electrical Nerve Stimulation: 1. For symptomatic relief and management of chronic pain 2. For adjunctive treatment in the management of post-surgical and post-traumatic pain 3. For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise and normal household and work activities Powered Muscle Stimulator 1. To temporarily increase local blood circulation in healthy muscles 2. For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance
    Device Description
    The HBOTC is an OTC electrical nerve and muscle stimulator indicated for symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow. The HBOTC consists of a portable battery-operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons for selecting the desired frequency and a dial to control the intensity of the signal. The stimulator is also supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display.
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