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510(k) Data Aggregation

    K Number
    K201431
    Device Name
    OGYILI TENS/NMES Stimulator
    Manufacturer
    Gongguan Tutamen Metalwork Co., LTD
    Date Cleared
    2020-11-09

    (161 days)

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

    Gongguan Tutamen Metalwork Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS function of the device is indicated for the following use: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain NMES function of the device is indicated for the following use: - 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 OGYILI TENS/NMES Stimulator E01 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The OGYILI TENS/NMES Stimulator is a programmable device that come equipped with 14 preset programs along with 14 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The OGYILI TENS/NMES Stimulator is programmed to default to program P- 14 which contains the most common setting. The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs. The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery. OGYILI TENS/NMES Stimulator package is comprised of the following items: - One TENS/NMES unit powered by DC 3.7-volt lithium battery ● - Two UL industry standard wires for electrodes conforming to FDA standards, ● - Four standard commercially available round 100 (mm) self adhesive electrodes. - One UL 110 battery rechargeable unit - Instruction manual. ● - Quick start instruction manual. ● - . Full package carrying case. The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.
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