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510(k) Data Aggregation

    K Number
    K063743
    Device Name
    RHYTHM TOUCH Q 2-WAY
    Date Cleared
    2007-05-24

    (157 days)

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

    SHOCKIM ENTERPRISES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
    Device Description
    The Rhythm Touch Q 2-Way is a dual channeled powered nerve stimulator. It electronically stimulates nerves. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires. The product is supplied with two sets of electrodes, a belt to fix and hold the unit and the electrodes, an instruction manual, and a set of batteries. Power is derived from two AAA cells located in a compartment protected by a removable battery cover. The electrodes provided with this model have 510(k) clearance. They are rectangular, 1.5"x1.75" in size. The lead wires also have 510(k) clearance.
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    K Number
    K032178
    Device Name
    RHYTHM TOUCH Q 2-WAY
    Date Cleared
    2003-10-15

    (91 days)

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

    SHOCKIM ENTERPRISES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. Indications For Use include: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion
    Device Description
    The Rhythm Touch Q 2-Way is a dual channeled powered muscle stimulator. It electronically stimulates muscles. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires. The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from two AAA cells located in a compartment protected by a removable battery cover. The electrodes, which are provided with this model, have 510(k) clearance. They are 2" x 2" in size. The leadwires also have 510(k) clearance.
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