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510(k) Data Aggregation

    K Number
    K152128
    Device Name
    2-in-1 Abdominal Muscle Training & Back Pain Relief System
    Date Cleared
    2015-12-23

    (145 days)

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

    Tohkai Precision Electrical Manufactory (Shenzhen) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two modes of stimulation; a transcutaneous electrical nerve stimulation (TENS) BP-313 mode and a powered muscle stimulation (PMS) TS-212 mode. The TENS (BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist. back, arm, leg due to strain from exercise or normal household and work activities. The PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    2-in-1 Abdominal Muscle Training & Back Pain Relief System is a portable multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities. 2-in-1 Abdominal Muscle Training & Back Pain Relief System has 12 operation modes, which can give certain electrical pulse through 4 of electrode pads placed on the skin to help users to enjoy body stimulation. The support belt which fastens around your waist provides appropriate stimulation position for a quick and easy exercise for users of all different waist sizes. The adhesive pads adhere to the belt to conduct the signal from the unit to your abdominal muscles. Snap cables are for connecting the stimulator and the support belt. Each unit comes with one battery (6F22/1604) so you can start exercising right away.
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