Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K242332
    Device Name
    Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd.
    Date Cleared
    2024-11-05

    (90 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.
    Device Description
    Not Found
    Ask a Question
    K Number
    K232517
    Device Name
    Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd.
    Date Cleared
    2023-12-08

    (112 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities(leg) due to strain from exercise or normal household work activities. For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with overthe-counter pain medications. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
    Device Description
    Not Found
    Ask a Question
    K Number
    K220998
    Device Name
    Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd.
    Date Cleared
    2022-08-24

    (142 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: - for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping - to temporarily increase local blood circulation in healthy leg muscles - to stimulate healthy muscles in order to improve and facilitate muscle performance - to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties - to relax muscle spasm - to increase blood flow circulation - for prevention of retardation of disuse atrophy - for muscle re-education - for maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Provide quadricep strengthening - Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: - symptomatic relief and management of chronic, intractable pain - relief of pain associated with arthritis - temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
    Device Description
    Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed model KTR-405 provides a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands. Modes 1-8 are for foot and can be switched to another mode for a minute automatically, while mode 9 is for knee and mode 10 for body. Modes for foot, knee and body can be switched manually during a session; 2) wonderful electric pulse combination, 0~150 levels can be adjusted and chosen according to personal preference; 3) rechargeable battery which can work up to 36 hours 4) wireless and rechargeable remote control allows easy control of the device 5) use while seated or reclining with Relax and Recline mode; 6)foot cover helps keep feet warm and cosy; 7) LCD display and power display make the operation simple and easy; 8) carry handle for easy transportation; 9) magnetic power cable for simple and safe connection. Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it can be run either from the mains power supply or via its internal rechargeable battery. To start therapy, you need to connect the device to the mains power supply. This will charge the battery, allowing you to use the device wirelessly in subsequent sessions. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.
    Ask a Question

    Page 1 of 1