Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K233067
    Device Name
    Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
    Manufacturer
    Chongqing Rob Linka Science And Technology Co., Ltd.
    Date Cleared
    2024-07-19

    (297 days)

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

    Chongqing Rob Linka Science And Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over-The-Counter Use: TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities. EMS/NMES: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Prescription Use: TENS: 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; EMS/NMES: 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 post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    Not Found
    Ask a Question
    K Number
    K233070
    Device Name
    Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
    Manufacturer
    Chongqing Rob Linka Science And Technology Co., Ltd.
    Date Cleared
    2024-03-13

    (169 days)

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

    Chongqing Rob Linka Science And Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SM9027 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs. The SM9037 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs. The SM9566 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs. The SM9065N Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
    Device Description
    Not Found
    Ask a Question
    K Number
    K233092
    Device Name
    Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
    Manufacturer
    Chongqing Rob Linka Science and Technology Co., Ltd.
    Date Cleared
    2024-02-12

    (139 days)

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

    Chongqing Rob Linka Science and Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-The-Counter Use: TENS: SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leq, due to strain from exercise or normal household and work activities. SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS/NMES: SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. SM9075 (mode 25-48), SM9910 (mode 9-16), SM9067 (mode 10-18), SM9587W (mode 9-18) are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. For Prescription Use: TENS: SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis PMS/NMES: SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are intended for the following use: - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
    Device Description
    Not Found
    Ask a Question
    K Number
    K230829
    Device Name
    TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
    Manufacturer
    Chongqing Rob Linka Science And Technology Co., Ltd.
    Date Cleared
    2023-04-26

    (30 days)

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

    Chongqing Rob Linka Science And Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1