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510(k) Data Aggregation

    K Number
    K183074
    Device Name
    TENS and EMS Stimulator, TENS Stimulator
    Date Cleared
    2020-01-11

    (432 days)

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

    Astek Technology Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS Stimulator (Model no .: AK-10M) TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain TENS and EMS Stimulator (Model no .: AK3-20 and AK3-25) TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode (1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis TENS and EMS Stimulator (Model no.: AK3-50) TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode (1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
    Device Description
    The TENS stimulator and TENS and EMS stimulator, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulators send gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of devices are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The four models have similar housing in a molded plastic case with viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD that control the program selection, strength, channel, and power. The TENS and EMS Stimulator (Model No .: AK3-20, AK3-25 and AK3-50) is the comination unit with the TENS and EMS functions; the function can be selected by press buttons. The range of settings is identical in models AK3-20 and AK3-25 while model AK3-50 provides 10 types of output modes.
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